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-0600-2025 | 07-07-2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. Package NDCs: 53329-811-30; 53329-811-09; 6122404005 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 6669874 swabs | Class II | Ongoing |
| D-0601-2025 | 07-07-2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30 Package NDCs: 53329-827-60; 53329-827-36; 53329-827-30; 53329-827-29; 53329-827-40; 53329-827-09; 53329-827-33; 6122405000 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 1,639,996 pads | Class II | Ongoing |
| D-0603-2025 | 07-07-2025 | H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09. Package NDCs: 37808-809-30; 37808-809-60; 37808-809-09; 6122408004 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 300000 pads | Class II | Ongoing |
| D-0605-2025 | 07-07-2025 | RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2. Package NDCs: 11822-5156-6; 11822-5156-2; 6122407008 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 984,000 pads | Class II | Ongoing |
| D-0543-2025 | 07-05-2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. | FDC Limited / 154,176 bottles | Class II | Ongoing |
| D-0542-2025 | 07-02-2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01. Package NDCs: 68180-755-01; 68180-755-02; 68180-755-03; 68180-756-01; 68180-756-02; 68180-756-03; 68180-459-01; 68180-459-02; 68180-459-03; 68180-472-01; 68180-472-02; 68180-472-03; 68180-463-01; 68180-463-02; 68180-463-03; 68180-473-01; 68180-473-02; 68180-473-03; 68180-759-01; 68180-759-02; 68180-759-03; 68180-760-01; 68180-760-02; 68180-760-03; 68180-757-01; 68180-757-02; 68180-757-03; 68180-758-01; 68180-758-02; 68180-758-03 | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 | Lupin Pharmaceuticals Inc. / 7668 bottles | Class II | Terminated |
| D-0530-2025 | 07-01-2025 | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870. | Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented. | Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles / 2 bags | Class II | Ongoing |
| D-0511-2025 | 06-30-2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33. 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 FDA recommended interim limit | Breckenridge Pharmaceutical, Inc. / 12,242 30-count bottles | Class II | Ongoing |
| D-0541-2025 | 06-30-2025 | Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton) Package NDCs: 69097-318-86; 69097-318-87; 69097-318-32; 69097-318-53; 69097-319-86; 69097-319-87; 69097-319-32; 69097-319-53; 69097-321-86; 69097-321-87; 69097-321-32; 69097-321-53 | Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. | Cipla USA, Inc. / 13,680 ampoules | Class II | Ongoing |
| D-0525-2025 | 06-30-2025 | Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10 Package NDCs: 82009-022-10 | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. | Dr. Reddy's Laboratories, Inc. / 1476 bottles | Class II | Ongoing |
| D-0537-2025 | 06-27-2025 | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01 Package NDCs: 68180-492-01; 68180-492-07; 68180-492-09; 68180-492-06; 68180-493-01; 68180-493-07; 68180-493-09; 68180-493-06; 68180-494-01; 68180-494-07; 68180-494-09; 68180-494-06 | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. | Lupin Pharmaceuticals Inc. / 2,724 bottles | Class II | Terminated |
| D-0569-2025 | 06-27-2025 | Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton). Package NDCs: 0781-3450-70; 0781-3450-95; 0781-3451-70; 0781-3451-96; 0781-3451-95 | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin | Sandoz Inc / 208,300 vials | Class I | Ongoing |
| D-0570-2025 | 06-27-2025 | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94. Package NDCs: 0781-6135-94; 0781-6135-95; 0781-6136-94 | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit | Sandoz Inc / unknown | Class I | Ongoing |
| D-0529-2025 | 06-26-2025 | Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 Package NDCs: 42291-906-90; 42291-907-90; 42291-905-90 | Failed Impurity/Degradation Specifications | AvKARE / 8,573 bottles | Class III | Ongoing |
| D-0528-2025 | 06-26-2025 | Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90 Package NDCs: 42291-906-90; 42291-907-90; 42291-905-90 | Failed Impurity/Degradation Specifications | AvKARE / 1,560 bottles | Class III | Ongoing |
| D-0510-2025 | 06-24-2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, Package NDCs: 70010-780-01; 70010-780-05; 70010-780-10; 70010-781-01; 70010-781-05; 70010-781-10; 70010-782-01; 70010-782-05; 70010-782-10; 70010-783-01; 70010-783-05; 70010-783-10 | Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. | Granules Pharmaceuticals Inc. / 27,648 100-count Bottles; 5,376 500-count Bottles | Class II | Ongoing |
| D-0522-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 4,896 bottles | Class II | Ongoing |
| D-0519-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 2,352 bottles | Class II | Ongoing |
| D-0532-2025 | 06-20-2025 | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01 Package NDCs: 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01 | Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg. | Lupin Pharmaceuticals Inc. / 58,968 bottles | Class II | Ongoing |
| D-0523-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 4,921 bottles | Class II | Ongoing |
| D-0518-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 82,159 bottles | Class II | Ongoing |
| D-0521-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 9,739 bottles | Class II | Ongoing |
| D-0524-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 2,344 bottles | Class II | Ongoing |
| D-0520-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15 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: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 54,227 bottles | Class II | Ongoing |
| D-0507-2025 | 06-19-2025 | Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61 | Defective container; blister packaging inadequately sealed. | The Harvard Drug Group LLC / 23,232 cartons | Class II | Ongoing |
| D-0508-2025 | 06-19-2025 | Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0 Package NDCs: 55154-3363-0; 55154-7992-0; 55154-7993-0 | Defective container; blister packaging inadequately sealed. | The Harvard Drug Group LLC / 3,527 bags | Class II | Ongoing |
| D-0516-2025 | 06-16-2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88 Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). | SUN PHARMACEUTICAL INDUSTRIES INC / 5,448 bottles | Class II | Ongoing |
| D-0517-2025 | 06-16-2025 | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01 | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. | Qualgen, LLC / 2,832 amber vials | Class III | Ongoing |
| D-0491-2025 | 06-16-2025 | 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10 | Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. | B BRAUN MEDICAL INC / 187,656 containers | Class II | Ongoing |
| D-0527-2025 | 06-11-2025 | Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98. Package NDCs: 0480-3632-98; 0480-3633-98; 0480-3631-98 | Failed Impurities/Degradation Specifications. | Orient Pharma Co., Ltd. Yunlin Plant / 20618 bottles | Class III | Ongoing |
| D-0526-2025 | 06-11-2025 | Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98. Package NDCs: 0480-3632-98; 0480-3633-98; 0480-3631-98 | Failed Impurities/Degradation Specifications. | Orient Pharma Co., Ltd. Yunlin Plant / 57504 bottles | Class III | Ongoing |
| D-0509-2025 | 06-11-2025 | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07. Package NDCs: 33342-024-07; 33342-025-07; 33342-026-07 | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. | Macleods Pharmaceuticals Ltd / 9,888/ 30 count bottles | Class III | Ongoing |
| D-0614-2025 | 06-10-2025 | KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026 | Subpotent Drug | IMMUNOCORE, LLC / 7,572 vials | Class II | Ongoing |
| D-0504-2025 | 06-06-2025 | ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5 | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Church & Dwight Inc / 3,374,918 cartons | Class I | Ongoing |
| D-0506-2025 | 06-06-2025 | Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2. | Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. | Church & Dwight Inc / 695,880 cartons | Class I | Ongoing |
| D-0505-2025 | 06-06-2025 | ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6 | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Church & Dwight Inc / 13,632 cartons | Class I | Ongoing |
| D-0501-2025 | 06-02-2025 | KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 14,725 vials | Class II | Ongoing |
| D-0502-2025 | 06-02-2025 | LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 2825 vials | Class II | Ongoing |
| D-0499-2025 | 06-02-2025 | BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 975 vials | Class II | Ongoing |
| D-0503-2025 | 06-02-2025 | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 4875 vials | Class II | Ongoing |
| D-0500-2025 | 06-02-2025 | KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 23,200 vials | Class II | Ongoing |
| D-0498-2025 | 06-02-2025 | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 29,700 vials | Class II | Ongoing |
| D-0488-2025 | 06-02-2025 | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Package NDCs: 65162-271-05; 65162-271-10; 65162-271-50; 65162-271-11; 65162-272-01; 65162-272-24; 65162-272-10; 65162-272-25; 65162-272-50 | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. | Amneal Pharmaceuticals, LLC / 6396 bottles | Class I | Ongoing |
| D-0497-2025 | 05-30-2025 | Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7. Package NDCs: 70710-1738-4; 70710-1592-7 | Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents. | Zydus Pharmaceuticals (USA) Inc / 11,616 bottles | Class II | Completed |
| D-0531-2025 | 05-30-2025 | TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01 | Marketed Without an Approved NDA/ANDA | Advanced Pharmaceutical Technology, Inc. / 26 vials | Class II | Ongoing |
| D-0472-2025 | 05-29-2025 | Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25 Package NDCs: 55150-401-01; 55150-401-25 | Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. | Eugia US LLC / 48,000 vials | Class II | Ongoing |
| D-0470-2025 | 05-29-2025 | Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44. Package NDCs: 33342-393-10; 33342-393-11; 33342-393-44; 33342-394-10; 33342-394-11; 33342-394-44; 33342-395-10; 33342-395-11; 33342-395-44; 33342-396-10; 33342-396-11; 33342-396-44; 33342-397-10; 33342-397-11; 33342-397-44; 33342-398-10; 33342-398-11; 33342-398-44; 33342-399-10; 33342-399-11; 33342-399-44; 33342-400-10; 33342-400-11; 33342-400-44; 33342-401-10; 33342-401-11; 33342-401-44; 33342-402-10; 33342-402-11; 33342-402-44; 33342-403-10; 33342-403-11; 33342-403-44; 33342-404-10; 33342-404-11; 33342-404-44 | Presence of a foreign substance: black hair found embedded in tablet. | Macleods Pharmaceuticals Ltd / 1,344- 1000 count bottles | Class III | Ongoing |
| D-0489-2025 | 05-28-2025 | DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62 Package NDCs: 0409-2344-01; 0409-2344-62; 0409-2344-02 | Discoloration; discolored solution from cracked vials | Pfizer Inc. / 98,410 vials | Class II | Ongoing |
| D-0494-2025 | 05-28-2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 Package NDCs: 60505-1003-1; 60505-1003-2 | Lack of Assurance of Sterility | Apotex Corp. / 87,840 bottles | Class II | Ongoing |
| D-0457-2025 | 05-28-2025 | Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4 | Defective Container: This recall is being initiated due to a leaking unit stored horizontally. | Apotex Corp. / 20,648 bottles | Class II | Ongoing |
| D-0496-2025 | 05-28-2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3 Package NDCs: 60505-0589-1; 60505-0589-2; 60505-0589-3 | Lack of Assurance of Sterility | Apotex Corp. / 6,288 Bottles | Class II | Ongoing |
| D-0495-2025 | 05-28-2025 | Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 Package NDCs: 60505-0578-4 | Lack of Assurance of Sterility | Apotex Corp. / 105,456 Bottles | Class II | Ongoing |
| D-0455-2025 | 05-27-2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 Package NDCs: 13668-443-74; 13668-443-10; 13668-443-01; 13668-443-30; 13668-443-91; 13668-473-10; 13668-473-74; 13668-473-30; 13668-473-01; 13668-473-91 | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Torrent Pharma Inc. / 3672 Bottles | Class II | Completed |
| D-0456-2025 | 05-27-2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) Package NDCs: 13668-443-74; 13668-443-10; 13668-443-01; 13668-443-30; 13668-443-91; 13668-473-10; 13668-473-74; 13668-473-30; 13668-473-01; 13668-473-91; 13668-473-70 | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Torrent Pharma Inc. / 972 Cartons | Class II | Completed |
| D-0490-2025 | 05-27-2025 | 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10 Package NDCs: 49230-300-10 | Lack of Assurance of Sterility | Fresenius Medical Care Holdings, Inc. / 3,651,468 containers | Class II | Ongoing |
| D-0458-2025 | 05-23-2025 | Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5 Package NDCs: 53329-202-13; 53329-202-04; 53329-202-08; 53329-202-70; 53329-202-84; 53329-202-85; 53329-202-74 | Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol | Consumer Product Partners, LLC / 125,040 bottles | Class II | Ongoing |
| D-0473-2025 | 05-23-2025 | Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01. Package NDCs: 0093-2204-01; 0093-2204-05; 0093-2203-01; 0093-2203-05; 0093-2203-10 | Presence of foreign tablets/capsules. | Teva Pharmaceuticals USA, Inc / 36612 cartons | Class II | Ongoing |
| D-0468-2025 | 05-23-2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. | Ascend Laboratories, LLC / 48,936 - 100 mL bottles | Class II | Ongoing |
| D-0469-2025 | 05-23-2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. | Ascend Laboratories, LLC / 10,620 - 200 mL bottles | Class II | Ongoing |
| D-0471-2025 | 05-22-2025 | Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10 Package NDCs: 72288-405-10 | cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). | Aurobindo Pharma USA Inc / 4,608 bottles | Class II | Ongoing |
| D-0487-2025 | 05-21-2025 | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 16 syringes | Class II | Ongoing |
| D-0483-2025 | 05-21-2025 | Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 826 syringes | Class II | Ongoing |
| D-0475-2025 | 05-21-2025 | CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 60 syringes | Class II | Ongoing |
| D-0479-2025 | 05-21-2025 | Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 32 syringes | Class II | Ongoing |
| D-0482-2025 | 05-21-2025 | Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 24 syringes | Class II | Ongoing |
| D-0476-2025 | 05-21-2025 | LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 64 syringes | Class II | Ongoing |
| D-0478-2025 | 05-21-2025 | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 16 syringes | Class II | Ongoing |
| D-0474-2025 | 05-21-2025 | Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 5 | Class II | Ongoing |
| D-0477-2025 | 05-21-2025 | LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 102 syringes | Class II | Ongoing |
| D-0486-2025 | 05-21-2025 | Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 242 syringes | Class II | Ongoing |
| D-0484-2025 | 05-21-2025 | Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 4 syringes | Class II | Ongoing |
| D-0485-2025 | 05-21-2025 | Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 216 syringes | Class II | Ongoing |
| D-0481-2025 | 05-21-2025 | Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 28 syringes | Class II | Ongoing |
| D-0480-2025 | 05-21-2025 | Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 164 syringes | Class II | Ongoing |
| D-0492-2025 | 05-21-2025 | UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295 | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. | Umary-USA.com / 1,342 30-count bottles | Class I | Completed |
| D-0493-2025 | 05-21-2025 | UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134 | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. | Umary-USA.com / 1,704 30-count bottles | Class I | Completed |
| D-0462-2025 | 05-19-2025 | Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90 Package NDCs: 68462-321-90; 68462-321-10; 68462-321-30; 68462-322-30; 68462-322-90; 68462-322-10; 68462-323-30; 68462-323-90; 68462-323-05; 68462-324-30; 68462-324-90; 68462-324-05 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study. | Glenmark Pharmaceuticals Inc., USA / 6,759 Con - 90 bottle pack | Class III | Ongoing |
| D-0452-2025 | 05-15-2025 | Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01 Package NDCs: 68462-380-01; 68462-380-05; 68462-356-01; 68462-356-05 | OOS results reported for the Dissolution (by UV) test. | Glenmark Pharmaceuticals Inc., USA / 8,520 100-count bottles | Class II | Ongoing |
| D-0441-2025 | 05-15-2025 | BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31. Package NDCs: 54365-400-31 | Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. | CareFusion 213, LLC / 385,200 applicators | Class II | Ongoing |
| D-0454-2025 | 05-15-2025 | Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card). Package NDCs: 68084-411-11; 68084-411-21 | cGMP deviations | Amerisource Health Services LLC / 21 cartons | Class II | Ongoing |
| D-0444-2025 | 05-14-2025 | Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, . Package NDCs: 0310-9080-12; 0310-9080-28 | Defective delivery system | AsttraZeneca Pharmaceuticals LP / a) 807,837 canisters; b) 235,698 canisters | Class II | Ongoing |
| D-0460-2025 | 05-13-2025 | Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 Package NDCs: 50268-168-11; 50268-168-15; 50268-169-11; 50268-169-15 | Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules | AvKARE / 3,817 50-count cartons | Class II | Ongoing |
| D-0442-2025 | 05-13-2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94 Package NDCs: 68382-848-94; 68382-849-94 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. | Zydus Pharmaceuticals (USA) Inc / 30,674 30 sachets/carton | Class II | Ongoing |
| D-0443-2025 | 05-13-2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94 Package NDCs: 68382-848-94; 68382-849-94 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. | Zydus Pharmaceuticals (USA) Inc / 22,152 30 sachets/carton | Class II | Ongoing |
| D-0446-2025 | 05-09-2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01. Package NDCs: 10702-026-03; 10702-026-01; 10702-026-10; 10702-027-03; 10702-027-01; 10702-027-10; 10702-028-03; 10702-028-01; 10702-028-10 | cGMP deviations | KVK Tech, Inc. / 9680 bottles | Class II | Ongoing |
| D-0445-2025 | 05-09-2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01. Package NDCs: 10702-016-03; 10702-016-06; 10702-016-09; 10702-016-01; 10702-016-50; 10702-016-10 | cGMP deviations | KVK Tech, Inc. / 9107 bottles | Class II | Ongoing |
| D-0459-2025 | 05-09-2025 | Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71 Package NDCs: 62332-140-30; 62332-140-60; 62332-140-91; 62332-140-08; 62332-141-30; 62332-141-31; 62332-141-91; 62332-141-08; 62332-141-60; 62332-141-71; 62332-142-30; 62332-142-31; 62332-142-91; 62332-142-71; 62332-142-08; 62332-142-60; 62332-143-30; 62332-143-60; 62332-143-71; 62332-143-10; 2405014780 | Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule | Alembic Pharmaceuticals Limited / 2,946 500-count bottles | Class II | Ongoing |
| D-0461-2025 | 05-09-2025 | Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15 Package NDCs: 50268-167-11; 50268-167-15 | Failed Dissolution Specifications | AvKARE / 962 cartons | Class II | Ongoing |
| D-0447-2025 | 05-07-2025 | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17 Package NDCs: 62332-508-17 | Failed Impurities/Degradation Specifications | Alembic Pharmaceuticals Limited / N/A | Class II | Ongoing |
| D-0453-2025 | 05-06-2025 | ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N | Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue). | EnShiShiXiangNiShangMaoYouXianGongSi / 600, 20-count cartons | Class I | Ongoing |
| D-0420-2025 | 05-02-2025 | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364. | Lack of Assurance of Sterility | Empower Clinic Services, LLC dba Empower Pharmacy / 8,230 vials | Class II | Ongoing |
| D-0410-2025 | 04-28-2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01. | CGMP Deviations | Siddha Flower Essences, LLC. / N/A | Class II | Ongoing |
| D-0412-2025 | 04-28-2025 | TESTOSTERONE PELLET 100 mg (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 2,762 vials | Class II | Ongoing |
| D-0413-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 1,974 vials | Class II | Ongoing |
| D-0414-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 355 vials | Class II | Ongoing |
| D-0416-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01 | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 1,964 vials | Class II | Ongoing |
| D-0415-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 1,447 vials | Class II | Ongoing |
| D-0401-2025 | 04-25-2025 | Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1 Package NDCs: 54643-5649-1; 54643-5657-1; 54643-5659-1; 54643-5650-2; 54643-5661-2; 54643-5663-2 | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. | Mckesson Medical-Surgical Inc. Corporate Office / 15 | Class II | Ongoing |
| D-0400-2025 | 04-25-2025 | Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01 | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. | Mckesson Medical-Surgical Inc. Corporate Office / 3 | Class II | Ongoing |
| D-0425-2025 | 04-24-2025 | KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 16,248 Jars | Class II | Terminated |
