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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0621-2026 | 05-18-2026 | PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO | Lack of Assurance of Sterility | PReye LLC / approximate 50 to 60 bottles | Class II | Ongoing |
| D-0593-2026 | 05-18-2026 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. | Subpotent Drug | IntegraDose Compounding Services LLC / 287 units | Class II | Ongoing |
| D-0551-2026 | 05-18-2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. Package NDCs: 11980-174-05; 11980-174-10 | Failed Stability Specifications | AbbVie Inc. / 2,736 bottles | Class III | Ongoing |
| D-0552-2026 | 05-18-2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 Package NDCs: 76420-760-01; 55150-164-02; 70121-1049-5; 67777-419-02 | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Eugia US LLC / 168,300 vials | Class III | Ongoing |
| D-0592-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0589-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0591-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0590-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0550-2026 | 05-14-2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. Package NDCs: 0536-5896-53; 0536-5896-88; 0536-5896-71; 0536-5895-53; 0536-5895-88; 0536-5895-71; 0536-5894-53; 0536-5894-88 | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. | AVEVA Drug Delivery Systems, Inc. / 59,808 pouches (4,272 Individual Folding Carton (IFC)) | Class III | Ongoing |
| D-0555-2026 | 05-14-2026 | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. Package NDCs: 76420-633-20; 76420-633-30; 76420-633-60; 76420-633-90; 76420-633-01; 76420-633-05; 76420-633-00; 76420-634-20; 76420-634-30; 76420-634-60; 76420-634-90; 76420-634-01; 76420-634-00; 76420-636-20; 76420-636-30; 76420-636-60; 76420-636-90; 76420-636-01; 76420-623-20; 76420-623-30; 76420-623-60; 76420-623-90; 76420-623-01; 76420-623-00 | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. | Asclemed USA Inc. / 50 bottles | Class II | Ongoing |
| D-0581-2026 | 05-14-2026 | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) Package NDCs: 63323-696-02; 63323-696-25 | Failed Impurities/Degradations Specifications | Fresenius Kabi USA, LLC / 898,050 vials | Class III | Ongoing |
| D-0543-2026 | 05-12-2026 | Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 Package NDCs: 70954-531-10; 70954-531-20; 70954-532-10; 70954-532-20; 70954-533-10; 70954-533-20; 70954-534-10; 70954-534-20; 70954-530-10; 70954-530-20 | Defective Container; packets were found to be either empty or partially full. | ANI Pharmaceuticals, Inc. / 3964 Cartons | Class II | Ongoing |
| D-0548-2026 | 05-12-2026 | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. | Subpotent Drug | IntegraDose Compounding Services LLC / 376 cassettes | Class II | Ongoing |
| D-0554-2026 | 05-12-2026 | Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. Package NDCs: 65282-1605-1 | Lack of Assurance of Sterility | Spectra Medical Devices, Llc / 210625 ampules | Class II | Ongoing |
| D-0580-2026 | 05-12-2026 | DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. Package NDCs: 72603-103-01; 72603-200-01 | Presence of Particulate matter: Particulate matter identified as glass. | SUN PHARMACEUTICAL INDUSTRIES INC / 675 vials | Class I | Ongoing |
| D-0542-2026 | 05-11-2026 | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. | Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. | Haleon US Holdings LLC / 285,330 blister cards | Class II | Ongoing |
| D-0546-2026 | 05-08-2026 | cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81. Package NDCs: 50474-700-62; 50474-700-61; 50474-710-79; 50474-710-80; 50474-710-81; 50474-750-10 | Lack of Assurance of Sterility | UCB Biosciences Inc. / 141,708 cartons | Class II | Ongoing |
| D-0556-2026 | 05-05-2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30. Package NDCs: 67877-499-30; 67877-499-90; 67877-500-30; 67877-500-90; 67877-501-30; 67877-501-90; 67877-502-30; 67877-502-90 | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications | Ascend Laboratories, LLC / 15,696 x 30's bottles | Class II | Ongoing |
| D-0539-2026 | 05-04-2026 | Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10. Package NDCs: 25021-241-10 | Failed Impurities/Degradation Specifications | Sagent Pharmaceuticals / Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. | Class III | Ongoing |
| D-0549-2026 | 05-01-2026 | Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08 | Presence of a Foreign Substance; black particles observed in liquid | Safecor Health, LLC / 520 syringes | Class II | Ongoing |
| D-0536-2026 | 05-01-2026 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 Package NDCs: 68084-203-11; 68084-203-01; 68084-202-11; 68084-202-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Amerisource Health Services LLC / 63,500 tablets | Class III | Ongoing |
| D-0537-2026 | 05-01-2026 | Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 Package NDCs: 68084-203-11; 68084-203-01; 68084-202-11; 68084-202-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Amerisource Health Services LLC / 225,000 tablets | Class III | Ongoing |
| D-0538-2026 | 04-30-2026 | Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 Package NDCs: 64380-472-01; 64380-472-02; 64380-473-01; 64380-473-02; 64380-474-01; 64380-474-02; 64380-475-01; 64380-475-02; 64380-476-01; 64380-476-02; 64380-477-01; 64380-477-05; 64380-478-01; 64380-478-02 | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. | Safecor Health, LLC / 149 capsules | Class II | Ongoing |
| D-0544-2026 | 04-29-2026 | Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1). Package NDCs: 70710-1047-3; 70710-1047-1; 70710-1047-5; 70710-1048-3; 70710-1048-1; 70710-1048-5 | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / 23,880 bottles | Class II | Ongoing |
| D-0514-2026 | 04-29-2026 | Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India Package NDCs: 27241-097-06; 27241-097-10; 27241-097-90; 27241-097-05; 27241-098-03; 27241-098-09; 27241-098-10; 27241-164-30; 27241-099-03; 27241-099-90; 27241-099-40 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Ajanta Pharma Ltd. / 312,894 packs | Class II | Ongoing |
| D-0516-2026 | 04-29-2026 | Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. Package NDCs: 27241-097-06; 27241-097-10; 27241-097-90; 27241-097-05; 27241-098-03; 27241-098-09; 27241-098-10; 27241-164-30; 27241-099-03; 27241-099-90; 27241-099-40 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Ajanta Pharma Ltd. / 117,168 packs | Class II | Ongoing |
| D-0545-2026 | 04-29-2026 | Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). Package NDCs: 70710-1047-3; 70710-1047-1; 70710-1047-5; 70710-1048-3; 70710-1048-1; 70710-1048-5 | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / 10,992 bottles | Class II | Ongoing |
| D-0515-2026 | 04-29-2026 | Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 Package NDCs: 27241-097-06; 27241-097-10; 27241-097-90; 27241-097-05; 27241-098-03; 27241-098-09; 27241-098-10; 27241-164-30; 27241-099-03; 27241-099-90; 27241-099-40 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Ajanta Pharma Ltd. / 77,376 packs. | Class II | Ongoing |
| D-0540-2026 | 04-28-2026 | Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07. Package NDCs: 0264-7750-07 | Presence of Particulate Matter. | B BRAUN MEDICAL INC / 95,412 containers | Class I | Ongoing |
| D-0535-2026 | 04-27-2026 | Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 Package NDCs: 51407-637-01; 51407-637-05; 51407-638-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Golden State Medical Supply Inc. / 1,620 bottles | Class III | Ongoing |
| D-0547-2026 | 04-27-2026 | Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 17,304 100-count bottles | Class II | Ongoing |
| D-0525-2026 | 04-27-2026 | Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1. Package NDCs: 42126-6400-1 | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. | Oasis Medical, Inc. / | Class II | Ongoing |
| D-0534-2026 | 04-27-2026 | Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 Package NDCs: 51407-637-01; 51407-637-05; 51407-638-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Golden State Medical Supply Inc. / 8,526 bottles | Class III | Ongoing |
| D-0533-2026 | 04-24-2026 | Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. Package NDCs: 0527-1301-01; 0527-1301-05; 0527-1301-10; 0527-1231-01; 0527-1231-05; 0527-1231-10 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Lannett Company Inc. / 44865 bottles | Class III | Ongoing |
| D-0541-2026 | 04-24-2026 | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03. Package NDCs: 70748-346-02; 70748-346-03 | Presence of particulate matter: a white thread-like structure in the cartridge | Lupin Pharmaceuticals Inc. / 217,621 pen injectors | Class II | Ongoing |
| D-0519-2026 | 04-24-2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21. 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 / 2,200 kits | Class II | Ongoing |
| D-0553-2026 | 04-24-2026 | MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037. | Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. | Wisconsin Pharmacal Company / 690 tubes | Class I | Ongoing |
| D-0501-2026 | 04-23-2026 | Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Thea Pharma, Inc. / | Class II | Ongoing |
| D-0500-2026 | 04-23-2026 | iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11 Package NDCs: 82584-700-05; 82584-700-11; 82584-700-13 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Thea Pharma, Inc. / | Class II | Ongoing |
| D-0520-2026 | 04-23-2026 | Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10. Package NDCs: 64980-685-01; 64980-685-10; 64980-686-01; 64980-686-10; 64980-687-01; 64980-687-10; 64980-688-01; 64980-688-10 | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test | JB Chemicals and Pharmaceuticals Ltd / 675 bottles | Class II | Ongoing |
| D-0517-2026 | 04-22-2026 | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42. Package NDCs: 54365-014-42; 54365-014-41 | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC / | Class II | Ongoing |
| D-0518-2026 | 04-22-2026 | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41 Package NDCs: 54365-014-42; 54365-014-41 | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC / | Class II | Ongoing |
| 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-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-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-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-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-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-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-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 | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. | Apotex Corp. / N/A | Class II | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0769-2026 | 03-21-2026 | Kian Pee Wan Capsules, 30-count bottles | Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. | Buy-Herbal / 71 bottles | Class I | 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-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-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-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 |
