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 September 11, 2026 and include a total of 17938 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0831-2026 | 08-24-2026 | Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228. Package NDCs: 76282-670-01; 76282-671-01; 76282-671-05; 76282-672-01; 76282-672-05; 76282-673-01; 76282-673-05 | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). | Hikma Pharmaceuticals USA INC. / a) 25,970 bottles; b) 2,384 bottles | Class II | Ongoing |
| N/A | 08-14-2026 | Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCNEIL, Pkg by: Safecor, Woburn, MA | Cross Contamination with Other Products | Safecor Health, LLC / 302 syringes | Not Yet Classified | Ongoing |
| D-0804-2026 | 08-13-2026 | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 Package NDCs: 60505-4377-3; 60505-4378-3; 60505-4379-3; 60505-3668-3; 60505-3669-3; 60505-3670-3 | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria | Apotex Corp. / 6,972 bottles | Class II | Ongoing |
| D-0832-2026 | 08-12-2026 | Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00 Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Presence of Particulate matter. | B BRAUN MEDICAL INC / 23,688 bags | Class I | Ongoing |
| D-0827-2026 | 08-10-2026 | Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20. Package NDCs: 65219-590-04; 65219-592-10; 65219-594-20 | Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. | Fresenius Kabi USA, LLC / 4,643 20mL-vials | Class I | Ongoing |
| D-0790-2026 | 08-10-2026 | Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205. | CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing | Church & Dwight Co., Inc. / 318,600 cartons | Class II | Ongoing |
| D-0771-2026 | 08-07-2026 | Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA Package NDCs: 51407-215-01; 51407-215-10 | CGMP deviations: tablets with black specks. | Golden State Medical Supply Inc. / 1200 bottles | Class II | Ongoing |
| D-0785-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0777-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0786-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0782-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0783-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0803-2026 | 08-06-2026 | Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2 Package NDCs: 63004-8710-1; 63004-8710-2; 63004-8712-1; 63004-8712-4; 63004-8711-1; 63004-8711-4 | Presence of particulate matter: glass and stopper piece | Mallinckrodt Hospital Products Inc. / 12367 vials | Class II | Ongoing |
| D-0781-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0775-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0784-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0776-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0779-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0778-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0780-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0745-2026 | 08-05-2026 | Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3. Package NDCs: 70710-1159-3; 70710-1159-9; 70710-1159-1; 70710-1160-3; 70710-1160-9; 70710-1160-1 | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. | Zydus Pharmaceuticals (USA) Inc / | Class II | Ongoing |
| D-0788-2026 | 08-04-2026 | Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11 Package NDCs: 76045-004-01; 76045-004-11; 76045-005-01; 76045-005-11; 76045-006-01; 76045-006-11; 76045-007-01; 76045-007-11; 76045-008-01; 76045-008-11 | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. | Fresenius Kabi USA, LLC / 625500 syringes | Class I | Ongoing |
| D-0746-2026 | 08-04-2026 | Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34 Package NDCs: 0078-0423-15; 0078-0358-34; 0078-1245-34; 0078-0359-34; 0078-1252-34; 0078-0360-34; 0078-1259-34 | Failed Dissolution Specifications | Novartis Pharmaceuticals Corporation / | Class II | Ongoing |
| D-0763-2026 | 08-03-2026 | SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08. | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 25 KG, 25 X 1.00 KG bags | Class II | Ongoing |
| D-0760-2026 | 08-03-2026 | TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02. | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 1KG - 100-0.1KG(100gm) bags | Class II | Ongoing |
| D-0759-2026 | 08-03-2026 | SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05 | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 25KG, 250-1gm bags | Class II | Ongoing |
| D-0789-2026 | 08-03-2026 | Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04. Package NDCs: 68180-956-01; 68180-956-02; 68180-956-03; 68180-956-04 | Failed content uniformity specifications. | Lupin Pharmaceuticals Inc. / 5082 tubes | Class II | Ongoing |
| D-0761-2026 | 08-03-2026 | TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04. | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 20 KG, 40 X 0.500KG(500gm) bags | Class II | Ongoing |
| D-0762-2026 | 08-03-2026 | TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08 | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 1KG - 20 X 1KG(1000gm) bags | Class II | Ongoing |
| D-0770-2026 | 08-03-2026 | Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3. Package NDCs: 51672-4041-1; 51672-4041-2; 51672-4041-9; 51672-4041-0; 51672-4050-1; 51672-4005-1; 51672-4005-2; 51672-4005-3; 51672-4123-6; 51672-4123-1; 51672-4123-3; 51672-4124-6; 51672-4124-1; 51672-4124-3; 51672-4125-6; 51672-4125-1; 51672-4125-3; 51672-4047-9; 51672-4047-4 | CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing | SUN PHARMACEUTICAL INDUSTRIES INC / 1968 Bottles (1000Tablets/Bottle) | Class II | Ongoing |
| D-0773-2026 | 07-31-2026 | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65. Package NDCs: 0019-1333-65; 0019-1323-65; 0019-1332-65 | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. | Liebel-Flarsheim Company LLC / 3,486 500mL-vials | Class I | Ongoing |
| D-0768-2026 | 07-30-2026 | CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51 Package NDCs: 23155-603-51 | Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. | Heritage Pharmaceuticals Inc / | Class II | Ongoing |
| D-0755-2026 | 07-29-2026 | SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 250 vials. | Class II | Ongoing |
| D-0752-2026 | 07-29-2026 | SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 4,748 vials. | Class II | Ongoing |
| D-0747-2026 | 07-29-2026 | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 56,918 vials. | Class II | Ongoing |
| D-0749-2026 | 07-29-2026 | SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 37,546 vials. | Class II | Ongoing |
| D-0757-2026 | 07-29-2026 | SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04. | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 4,250 vials. | Class II | Ongoing |
| D-0756-2026 | 07-29-2026 | SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 500 vials. | Class II | Ongoing |
| D-0750-2026 | 07-29-2026 | SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 9,762 vials. | Class II | Ongoing |
| D-0753-2026 | 07-29-2026 | SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 250 vials. | Class II | Ongoing |
| D-0754-2026 | 07-29-2026 | SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 250 vials. | Class II | Ongoing |
| D-0766-2026 | 07-29-2026 | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3 Package NDCs: 67172-999-01; 67172-999-06 | Lack of assurance of sterility. The recall is due to potential contamination | Prestige Brands Holdings / 39,060 15mL-bottles | Class II | Ongoing |
| D-0751-2026 | 07-29-2026 | SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 24,608 vials. | Class II | Ongoing |
| D-0748-2026 | 07-29-2026 | SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 23,029 vials. | Class II | Ongoing |
| D-0765-2026 | 07-29-2026 | PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1 Package NDCs: 70121-2453-1; 70121-2461-1; 70121-2462-1 | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials | Shilpa Medicare Limited / 9,489 50mL vials | Class II | Ongoing |
| D-0764-2026 | 07-29-2026 | PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1 Package NDCs: 70121-2453-1; 70121-2461-1; 70121-2462-1 | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials | Shilpa Medicare Limited / 18,434 10mL vials | Class II | Ongoing |
| D-0767-2026 | 07-28-2026 | Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01 Package NDCs: 61755-008-01; 8494000002 | Lack of Assurance of Sterility | Regeneron Pharmaceuticals Inc / 21,353 vials | Class II | Ongoing |
| D-0794-2026 | 07-24-2026 | AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967. Package NDCs: 0517-9120-25; 0517-9120-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 63,200 vials | Class II | Ongoing |
| D-0795-2026 | 07-24-2026 | Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967. Package NDCs: 0517-1004-01; 0517-1004-25; 0517-1001-01; 0517-1001-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 89,775 vials | Class II | Ongoing |
| D-0792-2026 | 07-24-2026 | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-0031-01; 0517-0031-25; 0517-0032-01; 0517-0032-25; 0517-0130-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 235,350 vials | Class II | Ongoing |
| D-0796-2026 | 07-24-2026 | ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-7504-25; 0517-7604-25; 0517-7510-03; 0517-7610-03; 0517-7630-03; 0517-7504-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 316,450 vials | Class II | Ongoing |
| D-0774-2026 | 07-24-2026 | Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80. Package NDCs: 0378-6333-80 | Failed Dissolution Specifications | Mylan Pharmaceuticals Inc / | Class II | Ongoing |
| D-0798-2026 | 07-24-2026 | Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-6560-01; 0517-6560-05; 0517-6502-01; 0517-6502-10 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 41,680 vials | Class II | Ongoing |
| D-0793-2026 | 07-24-2026 | Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-0031-01; 0517-0031-25; 0517-0032-01; 0517-0032-25; 0517-0130-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 26,450 vials | Class II | Ongoing |
| D-0791-2026 | 07-24-2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967. Package NDCs: 0517-4810-01; 0517-4810-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 98,200 vials | Class II | Ongoing |
| D-0801-2026 | 07-24-2026 | Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-9305-01; 0517-9305-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 323,000 vials | Class II | Ongoing |
| D-0799-2026 | 07-24-2026 | Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-9302-01; 0517-9302-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 185,775 vials | Class II | Ongoing |
| D-0797-2026 | 07-24-2026 | ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-7504-25; 0517-7604-25; 0517-7510-03; 0517-7610-03; 0517-7630-03; 0517-7604-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 169,200 vials | Class II | Ongoing |
| D-0787-2026 | 07-24-2026 | Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41. Package NDCs: 0338-3508-41; 0338-3503-41; 0338-0096-06 | Presence of Particulate Matter | Baxter Healthcare Corporation / 19,032 bags | Class I | Ongoing |
| D-0802-2026 | 07-24-2026 | niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054. Package NDCs: 72572-470-01; 72572-470-10 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 43,460 vials | Class II | Ongoing |
| D-0800-2026 | 07-24-2026 | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-4002-01; 0517-4002-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde | American Regent, Inc. / 86,100 vials | Class I | Ongoing |
| D-0731-2026 | 07-23-2026 | Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52. Package NDCs: 68462-626-52 | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0733-2026 | 07-23-2026 | Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99 Package NDCs: 59651-719-01; 59651-719-99 | shortfill; reports of empty capsules. | Aurobindo Pharma USA Inc / 6,408 bottles distributed to market | Class II | Ongoing |
| D-0730-2026 | 07-22-2026 | Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26. Package NDCs: 42571-147-26 | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. | MICRO LABS USA INC / N/A | Class II | Ongoing |
| D-0744-2026 | 07-17-2026 | Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1 | Presence of Particulate Matter; identified as stainless steel | Sunny Pharmtech Inc. / 1,464 vials | Class I | Ongoing |
| D-0743-2026 | 07-17-2026 | Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1 | Presence of Particulate Matter; identified as stainless steel | Sunny Pharmtech Inc. / 4,077 vials | Class I | Ongoing |
| D-0727-2026 | 07-16-2026 | Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05 Package NDCs: 63323-286-01; 63323-286-20; 63323-286-05; 63323-286-23; 63323-286-09; 63323-286-31; 63323-286-11; 63323-286-35; 63323-286-03; 63323-286-00; 63323-286-33; 63323-286-63; 63323-286-30; 63323-287-01; 63323-287-20; 63323-287-03; 63323-287-21; 63323-288-01; 63323-288-10; 63323-288-06; 63323-288-20; 63323-288-03; 63323-288-11; 63323-288-07; 63323-288-21; 63323-285-01; 63323-285-10; 63323-285-06; 63323-285-20; 63323-285-03; 63323-285-13; 63323-285-07; 63323-285-23; 63323-285-57; 63323-285-64; 63323-285-51; 63323-285-65; 63323-285-02; 63323-285-61; 63323-285-04; 63323-285-63 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 92,600 vials | Class II | Ongoing |
| D-0740-2026 | 07-16-2026 | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418 | Incorrect Product Formulation | Central Admixture Pharmacy Services Inc / (2) patient-specific TPN prescriptions | Class III | Ongoing |
| D-0737-2026 | 07-16-2026 | Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability | Ascend Laboratories, LLC / 3,600 cartons x 6 x 10 (in blister pack) | Class III | Ongoing |
| D-0725-2026 | 07-16-2026 | Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07 Package NDCs: 63323-578-03; 63323-578-01; 63323-578-04; 63323-578-02; 63323-578-07; 63323-578-05; 63323-578-18; 63323-578-20 | Presence of Particulate Matter: Hair was found in product | Fresenius Kabi USA, LLC / 59,425 vials | Class II | Ongoing |
| D-0726-2026 | 07-16-2026 | Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01 Package NDCs: 63323-208-01; 63323-208-05 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 181,225 vials | Class II | Ongoing |
| D-0738-2026 | 07-16-2026 | Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability | Ascend Laboratories, LLC / 924 cartons x 12 x 6 x 10 (in blister pack) | Class III | Ongoing |
| D-0739-2026 | 07-16-2026 | Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability | Ascend Laboratories, LLC / 936 cartons x 12 x 3 x 10 (in blister pack) | Class III | Ongoing |
| D-0729-2026 | 07-16-2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03 Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 37,250 vials | Class II | Ongoing |
| D-0728-2026 | 07-16-2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01 Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 93,250 vials | Class II | Ongoing |
| D-0713-2026 | 07-15-2026 | Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. 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 | Asclemed USA Inc. / 18 kits | Class III | Ongoing |
| D-0741-2026 | 07-14-2026 | Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case). Package NDCs: 68094-073-01; 68094-073-58 | Failed Impurities/Degradation Specifications | Precision Dose Inc. / N/A | Class II | Ongoing |
| D-0720-2026 | 07-14-2026 | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1 Package NDCs: 10742-8162-1; 10742-8162-2; 3107420111 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 97201 cartons | Class II | Ongoing |
| D-0716-2026 | 07-14-2026 | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1 Package NDCs: 10742-8158-1; 10742-8158-2; 3107420110 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 6076306 cartons | Class II | Ongoing |
| D-0715-2026 | 07-14-2026 | Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1 Package NDCs: 10742-8146-1; 3107420108 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 1.033,266 cartons | Class II | Ongoing |
| D-0721-2026 | 07-14-2026 | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2 Package NDCs: 10742-8162-1; 10742-8162-2; 3107420111 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 353 cartons | Class II | Ongoing |
| D-0718-2026 | 07-14-2026 | Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1 Package NDCs: 10742-8160-1; 3107420109 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 1,278,457 cartons | Class II | Ongoing |
| D-0722-2026 | 07-14-2026 | Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1 Package NDCs: 10742-8141-1; 3107420107 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 2910148 cartons | Class II | Ongoing |
| D-0719-2026 | 07-14-2026 | Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1 Package NDCs: 10742-8175-1; 3107420106 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 65219 cartons | Class II | Ongoing |
| D-0717-2026 | 07-14-2026 | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2 Package NDCs: 10742-8158-1; 10742-8158-2; 3107420112 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 499,673 cartons | Class II | Ongoing |
| D-0702-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0711-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61 Package NDCs: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0710-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61 Package NDCs: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0705-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0703-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0708-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61 Package NDCs: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0706-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0724-2026 | 07-13-2026 | Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48. Package NDCs: 64980-504-48 | Presence of Precipitate: medication was crystallizing and particles floating in the bottle | Rising Pharma Holding, Inc. / 74208 units | Class II | Ongoing |
| D-0700-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0707-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61 Package NDCs: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0701-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0709-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61 Package NDCs: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0704-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0690-2026 | 07-09-2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31 Package NDCs: 54365-400-31 | Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator | CareFusion 213, LLC / 43,066,599 units | Class II | Ongoing |
| D-0712-2026 | 07-08-2026 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30 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 / 6,192 bottles | Class II | Ongoing |
