Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on June 19, 2026 and include a total of 17711 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0443-2026 | 03-25-2026 | Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0 Package NDCs: 68788-7266-0 | Lack of Assurance of Sterility | Preferred Pharmaceuticals, Inc. / 720 bottles | Class II | Ongoing |
| D-0485-2026 | 03-24-2026 | Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61 Package NDCs: 0904-6734-61; 0904-6736-61; 0904-6737-61; 0904-6735-61 | Failed Dissolution Specifications | The Harvard Drug Group LLC / N/A | Class II | Ongoing |
| D-0448-2026 | 03-24-2026 | GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91. Package NDCs: 0407-1401-52; 0407-1411-10; 0407-1411-20; 0407-1412-10; 0407-1412-20; 0407-1412-50; 0407-1412-29; 0407-1412-30; 0407-1412-60; 0407-1412-33; 0407-1412-27; 0407-1412-49; 0407-1412-34; 0407-1412-28; 0407-1412-35; 0407-1413-11; 0407-1413-10; 0407-1413-59; 0407-1413-30; 0407-1413-50; 0407-1413-51; 0407-1413-61; 0407-1413-95; 0407-1413-98; 0407-1413-62; 0407-1413-99; 0407-1413-60; 0407-1413-63; 0407-1413-91; 0407-1413-53; 0407-1413-90; 0407-1413-65; 0407-1413-92; 0407-1413-66; 0407-1413-93; 0407-1413-96; 0407-1413-69; 0407-1414-21; 0407-1414-50; 0407-1414-51; 0407-1414-52; 0407-1414-89; 0407-1414-20; 0407-1414-90; 0407-1414-22; 0407-1414-53; 0407-1414-60; 0407-1414-91; 0407-1414-76; 0407-1414-03; 0407-1414-23; 0407-1414-93; 0407-1414-04; 0407-1414-94; 0407-1414-24; 0407-1414-80; 0407-1414-95; 0407-1415-09; 0407-1416-12 | Presence of particulate matter | GE Healthcare Ireland Limited / 306,810 vials | Class II | Ongoing |
| D-0447-2026 | 03-24-2026 | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. Package NDCs: 0407-1401-52; 0407-1411-10; 0407-1411-20; 0407-1412-10; 0407-1412-20; 0407-1412-50; 0407-1412-29; 0407-1412-30; 0407-1412-60; 0407-1412-33; 0407-1412-27; 0407-1412-49; 0407-1412-34; 0407-1412-28; 0407-1412-35; 0407-1413-11; 0407-1413-10; 0407-1413-59; 0407-1413-30; 0407-1413-50; 0407-1413-51; 0407-1413-61; 0407-1413-95; 0407-1413-98; 0407-1413-62; 0407-1413-99; 0407-1413-60; 0407-1413-63; 0407-1413-91; 0407-1413-53; 0407-1413-90; 0407-1413-65; 0407-1413-92; 0407-1413-66; 0407-1413-93; 0407-1413-96; 0407-1413-69; 0407-1414-21; 0407-1414-50; 0407-1414-51; 0407-1414-52; 0407-1414-89; 0407-1414-20; 0407-1414-90; 0407-1414-22; 0407-1414-53; 0407-1414-60; 0407-1414-91; 0407-1414-76; 0407-1414-03; 0407-1414-23; 0407-1414-93; 0407-1414-04; 0407-1414-94; 0407-1414-24; 0407-1414-80; 0407-1414-95; 0407-1415-09; 0407-1416-12 | Presence of particulate matter | GE Healthcare Ireland Limited / 866,570 vials | Class II | Ongoing |
| D-0461-2026 | 03-20-2026 | MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085 Package NDCs: 83698-125-25; 83698-125-70; 3831730000 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0439-2026 | 03-20-2026 | norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Fagron Compounding Services / 5140 bags | Class II | Ongoing |
| D-0462-2026 | 03-20-2026 | MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047. Package NDCs: 83698-114-30; 83698-114-80; 3831730000 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0468-2026 | 03-20-2026 | QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673. Package NDCs: 83698-617-30; 6355159867 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0441-2026 | 03-20-2026 | Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Fagron Compounding Services / 16,130 bags | Class II | Ongoing |
| D-0442-2026 | 03-20-2026 | Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01 | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Fagron Compounding Services / 11,680 bags | Class II | Ongoing |
| D-0438-2026 | 03-20-2026 | norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02 | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Fagron Compounding Services / 25,260 bags | Class II | Ongoing |
| D-0459-2026 | 03-20-2026 | Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092. Package NDCs: 83698-150-30; 83698-150-80; 0933510370 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0466-2026 | 03-20-2026 | QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. Package NDCs: 83698-616-25; 6355159933 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0460-2026 | 03-20-2026 | Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085. Package NDCs: 83698-102-30; 0933510370 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0470-2026 | 03-20-2026 | QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411. Package NDCs: 83698-620-30; 6355159994 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0463-2026 | 03-20-2026 | MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030. Package NDCs: 83698-114-30; 83698-114-80; 3831730000 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0465-2026 | 03-20-2026 | QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. Package NDCs: 83698-616-25; 6355159933 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0469-2026 | 03-20-2026 | QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718. Package NDCs: 83698-675-30; 6355159867 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0458-2026 | 03-20-2026 | caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407. Package NDCs: 83698-421-90; 8100259284 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0486-2026 | 03-20-2026 | Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 Package NDCs: 69315-116-01; 69315-116-10; 69315-117-01; 69315-117-10; 69315-118-01; 69315-118-05 | CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. | Leading Pharma, LLC / 9384 bottles | Class II | Ongoing |
| D-0456-2026 | 03-20-2026 | exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870. Package NDCs: 83698-580-30; 6142993988 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0440-2026 | 03-20-2026 | Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01 | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Fagron Compounding Services / 34,260 bags | Class II | Ongoing |
| D-0467-2026 | 03-20-2026 | QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398. Package NDCs: 83698-625-30; 6355159993 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0464-2026 | 03-20-2026 | QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. Package NDCs: 83698-616-25; 6355159933 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0457-2026 | 03-20-2026 | exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887. Package NDCs: 83698-581-30; 6142993988 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. / N/A | Class II | Ongoing |
| D-0472-2026 | 03-19-2026 | Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch Package NDCs: 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04 | CGMP Deviations: use of an unapproved raw material | Teva Pharmaceuticals USA, Inc / 124,054 Cartons | Class II | Ongoing |
| D-0473-2026 | 03-19-2026 | Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch Package NDCs: 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04 | CGMP Deviations: use of an unapproved raw material | Teva Pharmaceuticals USA, Inc / 62,136 Cartons | Class II | Ongoing |
| D-0474-2026 | 03-19-2026 | Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch Package NDCs: 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04 | CGMP Deviations: use of an unapproved raw material | Teva Pharmaceuticals USA, Inc / 113,943 Cartons | Class II | Ongoing |
| D-0408-2026 | 03-19-2026 | traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5. Package NDCs: 60219-2348-4; 60219-2348-1; 60219-2348-5; 60219-2348-7 | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). | Amneal Pharmaceuticals, LLC / 29,542 bottles | Class II | Ongoing |
| D-0478-2026 | 03-18-2026 | Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3. Package NDCs: 70121-1719-9; 70121-1719-2; 70121-1720-9; 70121-1720-3 | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. | Amneal Pharmaceuticals, LLC / 784 (12x100mL) cartons | Class I | Ongoing |
| D-0482-2026 | 03-18-2026 | Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05 | Subpotent Drug | Island Kinetics, Inc. d.b.a. CoValence Laboratories / 299 bottles | Class III | Ongoing |
| D-0481-2026 | 03-18-2026 | Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04 | Subpotent Drug | Island Kinetics, Inc. d.b.a. CoValence Laboratories / 2895 bottles | Class III | Ongoing |
| D-0480-2026 | 03-18-2026 | Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13 | Subpotent Drug | Island Kinetics, Inc. d.b.a. CoValence Laboratories / 1060 bottles | Class III | Ongoing |
| D-0402-2026 | 03-17-2026 | CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. Package NDCs: 10122-510-03; 10122-510-01 | Lack of Assurance of Sterility | Chiesi USA, Inc. / 7,235 vials | Class II | Ongoing |
| D-0479-2026 | 03-17-2026 | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05. | Labelling: Illegible label | Nephron SC, LLC / 146,280 vials | Class II | Ongoing |
| D-0404-2026 | 03-17-2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. Package NDCs: 0480-9257-08; 0480-9256-01; 0480-9263-21; 0480-9259-08; 0480-9258-01; 0480-9262-08; 0480-9260-01 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Teva Pharmaceuticals USA, Inc / 1,897 Cartons | Class II | Ongoing |
| D-0405-2026 | 03-17-2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. Package NDCs: 0480-9257-08; 0480-9256-01; 0480-9263-21; 0480-9259-08; 0480-9258-01; 0480-9262-08; 0480-9260-01 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Teva Pharmaceuticals USA, Inc / 19,869 Cartons | Class II | Ongoing |
| D-0406-2026 | 03-17-2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. Package NDCs: 0480-9257-08; 0480-9256-01; 0480-9263-21; 0480-9259-08; 0480-9258-01; 0480-9262-08; 0480-9260-01 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Teva Pharmaceuticals USA, Inc / 21,930 Cartons | Class II | Ongoing |
| D-0444-2026 | 03-17-2026 | Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91 Package NDCs: 58151-503-91; 58151-504-91; 58151-505-91; 58151-506-91 | Failed Dissolution Specifications | Viatris, Inc. / | Class II | Ongoing |
| D-0450-2026 | 03-16-2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Cipla USA, Inc. / 96,096 bottles | Class II | Ongoing |
| D-0449-2026 | 03-16-2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Cipla USA, Inc. / 113,336 bottles | Class II | Ongoing |
| D-0418-2026 | 03-16-2026 | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. Package NDCs: 60687-775-11; 60687-775-01; 60687-775-65; 60687-730-11; 60687-730-01; 60687-730-65 | Failed tablet specifications. | Amerisource Health Services LLC / 697 cartons | Class II | Ongoing |
| D-0451-2026 | 03-16-2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Cipla USA, Inc. / 63,192 bottles | Class II | Ongoing |
| D-0527-2026 | 03-13-2026 | Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. Package NDCs: 42023-179-05 | Presence of particulate matter: identified as Buprenorphine free base | ENDO USA, Inc. / 34,293 vials | Class II | Ongoing |
| D-0423-2026 | 03-13-2026 | Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67 Package NDCs: 69097-907-67; 69097-908-67; 69097-906-67 | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. | Cipla USA, Inc. / | Class II | Ongoing |
| D-0422-2026 | 03-13-2026 | Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 Package NDCs: 69097-880-67; 69097-890-67; 69097-870-67 | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. | Cipla USA, Inc. / 54,583 syringes | Class II | Ongoing |
| D-0434-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0429-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0433-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10. Package NDCs: 65219-282-01; 65219-282-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0426-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0424-2026 | 03-11-2026 | 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). Package NDCs: 63323-626-01; 63323-626-50; 63323-626-02; 63323-626-00; 63323-626-03; 63323-626-25; 63323-626-04; 63323-626-55; 63323-626-05; 63323-626-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0428-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0430-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0437-2026 | 03-11-2026 | 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30. Package NDCs: 65219-456-05; 65219-456-60; 65219-464-05; 65219-464-50; 65219-458-05; 65219-458-30; 65219-460-05; 65219-460-20; 65219-462-05; 65219-462-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0431-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0425-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0435-2026 | 03-11-2026 | 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60. Package NDCs: 65219-456-05; 65219-456-60; 65219-464-05; 65219-464-50; 65219-458-05; 65219-458-30; 65219-460-05; 65219-460-20; 65219-462-05; 65219-462-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0432-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. Package NDCs: 65219-432-20; 65219-432-85; 65219-328-10; 65219-328-50 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0427-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0436-2026 | 03-11-2026 | 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50. Package NDCs: 65219-456-05; 65219-456-60; 65219-464-05; 65219-464-50; 65219-458-05; 65219-458-30; 65219-460-05; 65219-460-20; 65219-462-05; 65219-462-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0400-2026 | 03-09-2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 Package NDCs: 70710-1738-4; 70710-1592-7 | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. | Zydus Pharmaceuticals (USA) Inc / 60,541 bottles | Class II | Ongoing |
| D-0471-2026 | 03-06-2026 | Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR | Lack of Assurance of Sterility | PAYLESS COMPOUNDERS, LLC / 91 vials | Class II | Ongoing |
| D-0407-2026 | 03-05-2026 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. Package NDCs: 60505-0589-1; 60505-0589-2; 60505-0589-3 | Lack of Assurance of Sterility | Apotex Corp. / 107,136 vials | Class II | Ongoing |
| D-0413-2026 | 03-03-2026 | Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3 Package NDCs: 50804-141-01; 24385-075-05; 0536-1217-94; 70000-0454-1; 41520-431-05 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 378,144 bottles | Class II | Ongoing |
| D-0411-2026 | 03-03-2026 | Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05 Package NDCs: 57896-181-05; 11822-1067-2; 70000-0502-1; 70000-0502-2; 70677-1158-1; 41250-718-01; 46122-605-05 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 1,023,096 bottles | Class II | Ongoing |
| D-0412-2026 | 03-03-2026 | Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9. Package NDCs: 70000-0457-1; 70000-0457-2; 70677-1160-1; 50804-160-01; 41250-937-01; 41250-937-02; 83324-029-15 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 245,184 bottles | Class II | Ongoing |
| D-0454-2026 | 03-03-2026 | SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232. | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 2269 bottles | Class II | Ongoing |
| D-0453-2026 | 03-03-2026 | HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027 | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 9,850 bottles | Class II | Ongoing |
| D-0455-2026 | 03-03-2026 | SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232. | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 2,500 bottles | Class II | Ongoing |
| D-0452-2026 | 03-03-2026 | FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 7,975 tubes | Class II | Ongoing |
| D-0410-2026 | 03-03-2026 | EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01. Package NDCs: 83324-191-14; 70677-1158-1; 50804-130-01; 83817-963-01 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 303,216 bottles | Class II | Ongoing |
| D-0384-2026 | 03-03-2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. Package NDCs: 16571-816-51; 16571-816-02; 16571-816-41; 16571-817-51; 16571-817-02; 16571-817-41; 16571-818-51; 16571-818-02; 16571-818-41; 16571-819-51; 16571-819-02; 16571-819-41; 16571-820-51; 16571-820-02; 16571-820-41; 16571-821-51; 16571-821-02 | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing | Rising Pharma Holding, Inc. / 1200 bottles | Class II | Ongoing |
| D-0415-2026 | 03-03-2026 | STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 74,016 bottles | Class II | Ongoing |
| D-0416-2026 | 03-03-2026 | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 Package NDCs: 70000-0011-1; 50804-110-01; 24385-006-05; 83324-189-14 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 589,848 bottles | Class II | Ongoing |
| D-0409-2026 | 03-03-2026 | Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7 Package NDCs: 83324-190-14; 50804-160-01; 41250-598-01 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 182,424 bottles | Class II | Ongoing |
| D-0414-2026 | 03-03-2026 | Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4 Package NDCs: 46122-606-05; 70000-0010-1; 70000-0010-2; 70677-1161-1; 11822-6453-4 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 315,144 bottles | Class II | Ongoing |
| D-0390-2026 | 03-02-2026 | Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8. Package NDCs: 51672-5321-8; 51672-5321-1 | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. | STRIDES PHARMA INC / 89592 bottles | Class II | Ongoing |
| D-0528-2026 | 03-02-2026 | Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085. | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Cardinal Health 200, LLC / 174,380,282 boxes | Class I | Ongoing |
| D-0395-2026 | 02-26-2026 | Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04. | Lack of Assurance of Sterility | New Life Pharma LLC / 45 vials | Class II | Ongoing |
| D-0392-2026 | 02-26-2026 | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07. | Lack of Assurance of Sterility | New Life Pharma LLC / 820 vials | Class II | Ongoing |
| D-0393-2026 | 02-26-2026 | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06 | Lack of Assurance of Sterility | New Life Pharma LLC / 2 vials | Class II | Ongoing |
| D-0394-2026 | 02-26-2026 | Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03. | Lack of Assurance of Sterility | New Life Pharma LLC / 23 vials | Class II | Ongoing |
| D-0403-2026 | 02-26-2026 | Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 Package NDCs: 33342-393-10; 33342-393-11; 33342-393-44; 33342-394-10; 33342-394-11; 33342-394-44; 33342-395-10; 33342-395-11; 33342-395-44; 33342-396-10; 33342-396-11; 33342-396-44; 33342-397-10; 33342-397-11; 33342-397-44; 33342-398-10; 33342-398-11; 33342-398-44; 33342-399-10; 33342-399-11; 33342-399-44; 33342-400-10; 33342-400-11; 33342-400-44; 33342-401-10; 33342-401-11; 33342-401-44; 33342-402-10; 33342-402-11; 33342-402-44; 33342-403-10; 33342-403-11; 33342-403-44; 33342-404-10; 33342-404-11; 33342-404-44 | Subpotent Drug | MACLEODS PHARMA USA, INC / 1315 bottles | Class II | Ongoing |
| D-0399-2026 | 02-24-2026 | Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93. Package NDCs: 0378-6611-85; 0378-6611-93; 0378-6612-85; 0378-6612-93; 0378-6613-85; 0378-6613-93; 0378-6614-85; 0378-6614-93 | Failed Dissolution Specifications | MYLAN PHARMACEUTICALS INC / 34850 blister packs | Class II | Ongoing |
| D-0401-2026 | 02-19-2026 | Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 Package NDCs: 69208-000-00; 69208-003-15; 69208-003-25; 69208-003-35 | Failed Tablet/Capsule Specifications | Radnostix / 2,699 blister cartons | Class III | Ongoing |
| D-0382-2026 | 02-18-2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 Package NDCs: 69097-030-08; 69097-030-16; 69097-030-63; 69097-031-17; 69097-031-56; 69097-031-74; 69097-031-76; 69097-031-73; 69097-031-91; 69097-032-17; 69097-032-56; 69097-032-74; 69097-032-76; 69097-032-73; 69097-032-91 | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. | Cipla USA, Inc. / 164 cartons | Class III | Ongoing |
| D-0381-2026 | 02-18-2026 | Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 Package NDCs: 69097-030-08; 69097-030-16; 69097-030-63; 69097-031-17; 69097-031-56; 69097-031-74; 69097-031-76; 69097-031-73; 69097-031-91; 69097-032-17; 69097-032-56; 69097-032-74; 69097-032-76; 69097-032-73; 69097-032-91 | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. | Cipla USA, Inc. / 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules | Class III | Ongoing |
| D-0387-2026 | 02-18-2026 | MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015. | Stability Data Does Not Support Expiry Date. | HTO Nevada Inc. dba Kirkman / 243 bottles | Class II | Ongoing |
| D-0385-2026 | 02-18-2026 | FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. | Stability Data Does Not Support Expiry Date. | HTO Nevada Inc. dba Kirkman / 27,380 bottles. | Class II | Ongoing |
| D-0386-2026 | 02-18-2026 | MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014. | Stability Data Does Not Support Expiry Date. | HTO Nevada Inc. dba Kirkman / 178 bottles | Class II | Ongoing |
| D-0383-2026 | 02-17-2026 | Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. Package NDCs: 0904-6817-06; 0904-6817-61; 0904-6818-06; 0904-6818-61; 0904-6819-07 | Defective container; inadequately sealed blister packaging. | The Harvard Drug Group LLC / 8892 cartons | Class II | Ongoing |
| D-0380-2026 | 02-13-2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution | Harbin Jixianglong Biotech Co., Ltd. / N/A | Class II | Ongoing |
| D-0379-2026 | 02-13-2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution | Harbin Jixianglong Biotech Co., Ltd. / N/A | Class II | Ongoing |
| D-0341-2026 | 02-13-2026 | Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. Package NDCs: 50268-069-11; 50268-069-15 | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. | AvKARE / N/A | Class II | Ongoing |
| D-0343-2026 | 02-12-2026 | Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 Package NDCs: 70436-026-80; 70436-027-80; 70436-162-80; 70436-163-80 | Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. | Slate Run Pharmaceuticals / N/A | Class III | Ongoing |
| D-0339-2026 | 02-10-2026 | Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, Package NDCs: 50222-346-01; 50222-346-02; 50222-346-22; 50222-346-04; 50222-346-91; 50222-346-92; 50222-350-00; 50222-350-01; 50222-350-02; 50222-350-90; 50222-350-91 | Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. | LEO PHARMA INC / 11,407 units | Class II | Ongoing |
| D-0340-2026 | 02-09-2026 | Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Package NDCs: 71288-558-90; 71288-556-02; 71288-557-81 | Defective Delivery System: Missing or duplicated needles within the injection kit | Meitheal Pharmaceuticals, Inc / 16,477 kits | Class II | Ongoing |
| D-0334-2026 | 02-05-2026 | ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56 | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / 1410 bags | Class II | Ongoing |
| D-0335-2026 | 02-05-2026 | thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56. | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / 10,548 bags | Class II | Ongoing |
| D-0337-2026 | 02-05-2026 | vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59. | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / N/A | Class II | Ongoing |
