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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0522-2026 | 04-21-2026 | Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Breckenridge Pharmaceutical, Inc. / 165,761 90-count bottles | Class II | Ongoing |
| D-0492-2026 | 04-21-2026 | GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01. Package NDCs: 0065-8064-01 | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. | Alcon Research LLC / | Class II | Ongoing |
| D-0491-2026 | 04-21-2026 | Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01 Package NDCs: 0065-0474-01; 0065-0474-02 | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. | Alcon Research LLC / | Class II | Ongoing |
| D-0523-2026 | 04-20-2026 | NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 Package NDCs: 42192-619-16 | Chemical contamination; presence of lead and lithium above specification | Acella Pharmaceuticals, LLC / 6,336 bottles | Class II | Ongoing |
| D-0499-2026 | 04-20-2026 | Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01. Package NDCs: 72972-002-01 | Lack of Assurance of Sterility | SCOPE HEALTH / | Class II | Ongoing |
| D-0489-2026 | 04-17-2026 | FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. | Lack of Assurance of Sterility | Harrow Eye LLC / 50,900 units | Class II | Ongoing |
| D-0494-2026 | 04-16-2026 | Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 Package NDCs: 0517-1045-01; 0517-1045-05; 0517-1075-01 | Labeling: Missing Label | American Regent, Inc. / 74,040 Single Dose Vials | Class III | Ongoing |
| D-0490-2026 | 04-14-2026 | Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08. Package NDCs: 48783-112-08 | Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed. | Premier Dental Products Co / 573 cartons | Class III | Ongoing |
| D-0511-2026 | 04-13-2026 | busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05. Package NDCs: 29300-244-01; 29300-244-05; 29300-245-01; 29300-245-05; 29300-246-01; 29300-246-18; 29300-246-05; 29300-246-16; 29300-247-16; 29300-247-01; 29300-247-05; 29300-477-16; 29300-477-01; 29300-477-18; 29300-477-05; 29300-478-16; 29300-478-01; 29300-478-05 | Subpotent drug | Unichem Pharmaceuticals USA Inc. / 10,875 Bottles | Class III | Ongoing |
| D-0493-2026 | 04-09-2026 | Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06 Package NDCs: 0904-7495-06 | Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. | The Harvard Drug Group LLC / 2,238 5 x 10 unit dose cartons | Class II | Ongoing |
| D-0697-2026 | 04-08-2026 | TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 Package NDCs: 63347-600-01 | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Blaine Labs Inc / 5,801 bottles | Class II | Ongoing |
| D-0695-2026 | 04-08-2026 | TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. Package NDCs: 63347-601-01 | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Blaine Labs Inc / 22,143 bottles | Class II | Ongoing |
| D-0693-2026 | 04-08-2026 | TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01. Package NDCs: 73352-520-01 | CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated | Blaine Labs Inc / 519 - 1 oz bottles | Class II | Ongoing |
| D-0510-2026 | 04-08-2026 | Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0 Package NDCs: 60505-0815-0 | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. | Apotex Corp. / N/A | Class II | Ongoing |
| D-0696-2026 | 04-08-2026 | vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2. | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Blaine Labs Inc / 26,475 bottles | Class II | Ongoing |
| D-0698-2026 | 04-08-2026 | Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Blaine Labs Inc / 1,500 bottles | Class II | Ongoing |
| D-0699-2026 | 04-08-2026 | Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670, Package NDCs: 63347-120-01; 63347-120-02 | CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated | Blaine Labs Inc / 5,555 bottles and tubes | Class II | Ongoing |
| D-0692-2026 | 04-08-2026 | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02. | Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp | Blaine Labs Inc / 1,171 - 1 oz bottles | Class I | Ongoing |
| D-0694-2026 | 04-08-2026 | TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01. Package NDCs: 73352-550-01 | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Blaine Labs Inc / 144 bottles | Class II | Ongoing |
| D-0509-2026 | 04-07-2026 | Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950 | Failed PH Specifications | Water-Jel Technologies, LLC / 31,488 tubes | Class III | Ongoing |
| D-0526-2026 | 04-07-2026 | Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59. Package NDCs: 0054-0282-59 | This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. | Hikma Pharmaceuticals USA INC / 4 single dose 75 ml bottles | Class II | Ongoing |
| D-0512-2026 | 04-06-2026 | DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Fresenius Medical Care Holdings, Inc. / 37,215 bags | Class II | Ongoing |
| D-0513-2026 | 04-06-2026 | DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Fresenius Medical Care Holdings, Inc. / 43,225 bags | Class II | Ongoing |
| D-0521-2026 | 04-06-2026 | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. Package NDCs: 0555-1054-60; 0555-1054-86; 0555-1054-56; 0555-1055-60; 0555-1055-86; 0555-1055-56; 0555-1056-60; 0555-1056-86; 0555-1057-60; 0555-1057-56; 0555-1057-86 | Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin | Teva Pharmaceuticals USA, Inc / 5,101 cartons | Class II | Ongoing |
| D-0532-2026 | 04-02-2026 | Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton) Package NDCs: 73293-0004-1; 73293-0004-2; 73293-0005-1; 73293-0005-2; 73293-0001-1; 73293-0001-2; 73293-0003-1; 73293-0003-2; 71351-026-20; 71351-026-25; 71351-027-20; 71351-027-25; 71351-021-05; 71351-021-10; 71351-021-25; 71351-023-05; 71351-023-10; 71351-023-25; 68094-081-01; 68094-081-25; 84769-0001-1; 84769-0001-2; 84769-0002-1; 84769-0002-2 | Lack of Assurance of Sterility | Huons Co., Ltd. / N/A | Class II | Ongoing |
| D-0530-2026 | 04-02-2026 | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules) Package NDCs: 73293-0002-1; 73293-0002-2; 71351-022-02; 71351-022-50; 71351-022-10 | Lack of Assurance of Sterility | Huons Co., Ltd. / 3,260,170 ampules | Class II | Ongoing |
| D-0529-2026 | 04-02-2026 | Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton) Package NDCs: 73293-0004-1; 73293-0004-2; 73293-0005-1; 73293-0005-2; 73293-0001-1; 73293-0001-2; 73293-0003-1; 73293-0003-2; 63739-170-13; 63739-170-24; 63739-170-27; 71351-026-20; 71351-026-25; 71351-027-20; 71351-027-25; 71351-021-05; 71351-021-10; 71351-021-25; 71351-023-05; 71351-023-10; 71351-023-25; 84769-0001-1; 84769-0001-2; 84769-0002-1; 84769-0002-2 | Lack of Assurance of Sterility | Huons Co., Ltd. / 33,599,925 ampules and 23658125 vials | Class II | Ongoing |
| D-0531-2026 | 04-02-2026 | 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. Package NDCs: 65282-1510-1; 65282-1505-1 | Lack of Assurance of Sterility | Huons Co., Ltd. / 7,120,750 ampules | Class II | Ongoing |
| D-0496-2026 | 04-02-2026 | DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50. Package NDCs: 0264-7387-50 | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. | B BRAUN MEDICAL INC / 17,124 bags | Class II | Ongoing |
| D-0497-2026 | 04-02-2026 | 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60. Package NDCs: 0264-7388-50; 0264-7388-60 | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. | B BRAUN MEDICAL INC / 124,244 bags | Class II | Ongoing |
| D-0498-2026 | 04-02-2026 | LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60. Package NDCs: 0264-7389-60 | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. | B BRAUN MEDICAL INC / 54,540 bags | Class II | Ongoing |
| D-0495-2026 | 04-02-2026 | Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60. Package NDCs: 0264-7385-50; 0264-7385-60 | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. | B BRAUN MEDICAL INC / 24,928 bags | Class II | Ongoing |
| D-0503-2026 | 04-01-2026 | fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02. | cGMP deviations. | Wells Pharma of Houston LLC / 4,030 IV Bags | Class II | Ongoing |
| D-0487-2026 | 04-01-2026 | Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9. | Failed Stability Specifications | Island Kinetics, Inc. d.b.a. CoValence Laboratories / 28,163 bottles | Class II | Ongoing |
| D-0506-2026 | 04-01-2026 | fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65. | cGMP deviations. | Wells Pharma of Houston LLC / 150 syringes | Class II | Ongoing |
| D-0507-2026 | 04-01-2026 | Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31. | cGMP deviations. | Wells Pharma of Houston LLC / 4975 syringes | Class II | Ongoing |
| D-0483-2026 | 04-01-2026 | EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1 Package NDCs: 76329-3318-1 | Lack of Assurance of Sterility | International Medication Systems Ltd. / 81,520 units | Class II | Ongoing |
| D-0502-2026 | 04-01-2026 | Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03 | cGMP deviations. | Wells Pharma of Houston LLC / 13,070 IV Bags | Class II | Ongoing |
| D-0504-2026 | 04-01-2026 | fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03. | cGMP deviations. | Wells Pharma of Houston LLC / 2940 IV Bags | Class II | Ongoing |
| D-0508-2026 | 04-01-2026 | fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15. | cGMP deviations. | Wells Pharma of Houston LLC / 50 syringes | Class II | Ongoing |
| D-0505-2026 | 04-01-2026 | fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25. | cGMP deviations. | Wells Pharma of Houston LLC / 50 syringes | Class II | Ongoing |
| D-0488-2026 | 03-31-2026 | Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1 | Subpotent drug | Avantor Performance Materials LLC / 36 bottles | Class III | Ongoing |
| D-0420-2026 | 03-27-2026 | Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. Package NDCs: 70377-066-11; 70377-067-11; 70377-068-11 | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. | Appco Pharma LLC / 58,896 bottles- 100's count | Class II | Ongoing |
| D-0421-2026 | 03-27-2026 | Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11. Package NDCs: 70377-066-11; 70377-067-11; 70377-068-11 | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. | Appco Pharma LLC / 28,157 bottles- 100's count | Class II | Ongoing |
| D-0419-2026 | 03-27-2026 | Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. Package NDCs: 70377-066-11; 70377-067-11; 70377-068-11 | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. | Appco Pharma LLC / 88,008 bottles- 100's count | Class II | Ongoing |
| D-0484-2026 | 03-26-2026 | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10 Package NDCs: 31722-712-90; 31722-712-32; 31722-712-31; 31722-713-90; 31722-713-32; 31722-713-31; 31722-713-10 | Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." | Hetero Labs Limited (Unit V) / 4,740 1,000-count bottles. | Class II | Ongoing |
| D-0475-2026 | 03-25-2026 | Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1 Package NDCs: 51672-1386-1; 51672-1386-2; 51672-1386-3; 51672-1386-4 | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. | SUN PHARMACEUTICAL INDUSTRIES INC / 24,672 15 g tubes | Class II | Ongoing |
| D-0476-2026 | 03-25-2026 | Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. Package NDCs: 51672-1386-1; 51672-1386-2; 51672-1386-3; 51672-1386-4 | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. | SUN PHARMACEUTICAL INDUSTRIES INC / 41,712 30g tubes | Class II | Ongoing |
| D-0477-2026 | 03-25-2026 | Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3. Package NDCs: 51672-1386-1; 51672-1386-2; 51672-1386-3; 51672-1386-4 | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. | SUN PHARMACEUTICAL INDUSTRIES INC / 2,640 60g tubes | Class II | Ongoing |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | Terminated |
| 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 | Terminated |
| 03-18-2026 | Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03. Package NDCs: 62332-583-03 | Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing. | ALEMBIC PHARMACEUTICALS, INC. / | 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-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 | Terminated |
| 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-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-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-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-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-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-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-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-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-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 | Crystallization; identified as Buprenorphine free base | ENDO USA, Inc. / 34,293 vials | 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-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-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-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 |
