Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0141-2026 | 10-10-2025 | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 935 cartons | Class III | Ongoing |
| D-0098-2026 | 10-09-2025 | Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N | Marketed Without an Approved NDA/ANDA | ibspot / 3 boxes | Class II | Ongoing |
| D-0025-2026 | 10-09-2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0027-2026 | 10-09-2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. | Amerisource Health Services LLC / 27,868 blister packs | Class II | Ongoing |
| D-0100-2026 | 10-09-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922. 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: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Breckenridge Pharmaceutical, Inc. / 172,263 bottles | Class II | Ongoing |
| D-0024-2026 | 10-09-2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0034-2026 | 10-09-2025 | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05 | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. | USV Private Limited / 8,952 bottles | Class II | Ongoing |
| D-0023-2026 | 10-09-2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0396-2026 | 10-08-2025 | Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0 | Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule). | Mohamed Hagar / 125 boxes | Class I | Ongoing |
| D-0028-2026 | 10-08-2025 | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30 Package NDCs: 0310-1730-30; 0310-1730-85; 0310-1830-30; 0310-1830-85; 0310-1745-01; 0310-1745-95 | Lack of Assurance of Sterility: | ASTRAZENECA PHARMACEUTICALS / 916 pre-filled syringes | Class II | Ongoing |
| D-0029-2026 | 10-07-2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01 Package NDCs: 16571-689-01; 16571-690-01; 16571-691-01; 16571-692-01; 16571-693-01; 16571-694-01 | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). | Rising Pharma Holding, Inc. / 2,064 100-count bottles | Class II | Ongoing |
| D-0104-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 181,659 bottles | Class II | Ongoing |
| D-0106-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 107,673 | Class II | Ongoing |
| D-0105-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 291,512 bottles | Class II | Ongoing |
| D-0107-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 6,979 bottles. | Class II | Ongoing |
| D-0109-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 5880 bottles. | Class II | Ongoing |
| D-0110-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 2,418 bottles. | Class II | Ongoing |
| D-0112-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 3,750 bottles. | Class II | Ongoing |
| D-0111-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 5,882 bottles. | Class II | Ongoing |
| D-0016-2026 | 10-06-2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. Package NDCs: 72578-102-04 | Discoloration | VIONA PHARMACEUTICALS INC / 13080 bottles | Class II | Ongoing |
| D-0108-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 8,754 bottles. | Class II | Ongoing |
| D-0258-2026 | 10-03-2025 | TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01 | Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. | Advanced Pharmaceutical Technology, Inc. / 22,843 pellets | Class II | Ongoing |
| D-0036-2026 | 10-01-2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). Package NDCs: 31722-305-25; 31722-305-10; 31722-306-25; 31722-307-25; 31722-307-02 | Presence of Particulate Matter: Particulate matter identified as glass | Aspiro Pharma Limited / | Class II | Ongoing |
| D-0095-2026 | 10-01-2025 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 Package NDCs: 10237-469-25; 10237-469-22 | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. | Church & Dwight Co., Inc. / 21,912 bottles | Class II | Ongoing |
| D-0035-2026 | 09-29-2025 | Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. | Subpotent Drug | Medline Industries, LP / 222,800 eaches | Class II | Ongoing |
| D-0005-2026 | 09-29-2025 | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum. | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. / | Class II | Ongoing |
| D-0004-2026 | 09-29-2025 | Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum. | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. / | Class II | Ongoing |
| D-0014-2026 | 09-29-2025 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. Package NDCs: 42192-501-50; 42192-501-05 | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. | Acella Pharmaceuticals, LLC / 4,680 500-count bottles | Class II | Ongoing |
| D-0008-2026 | 09-26-2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25 Package NDCs: 43598-666-11; 43598-666-25 | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. | Dr. Reddy's Laboratories, Inc. / 571 vials | Class II | Ongoing |
| D-0022-2026 | 09-25-2025 | Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344 | cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. | SV Labs Prescott Corporation / 11,386 tubes | Class II | Ongoing |
| D-0001-2026 | 09-24-2025 | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc / 912 30-count bottles | Class II | Ongoing |
| D-0002-2026 | 09-24-2025 | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc / 600 30-count bottles | Class II | Ongoing |
| D-0178-2026 | 09-23-2025 | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1. | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. | Park Avenue Compounding / 189 bags | Class II | Ongoing |
| D-0122-2026 | 09-23-2025 | Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015 | Product Mix-up | ACME UNITED CORPORATION / 2338 boxes | Class II | Ongoing |
| D-0003-2026 | 09-22-2025 | Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436. | Lack of assurance of sterility. | RC Outsourcing, LLC / 2,669 syringes | Class II | Terminated |
| D-0020-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0017-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 141,984 bottles | Class II | Ongoing |
| D-0018-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0019-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0662-2025 | 09-17-2025 | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52 Package NDCs: 68462-626-52 | CGMP Deviations: Market complaints received for gritty texture (grainy) | Glenmark Pharmaceuticals Inc., USA / 13824 tubes | Class II | Ongoing |
| D-0200-2026 | 09-17-2025 | Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1. | CGMP Deviations | Park Avenue Compounding / 858 syringes | Class II | Ongoing |
| D-0006-2026 | 09-16-2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15. 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: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. | ACCORD HEALTHCARE, INC. / 54,432 bottles | Class II | Ongoing |
| D-0015-2026 | 09-16-2025 | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1 | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | IntegraDose Compounding Services LLC / 853/500 mL bags | Class I | Ongoing |
| D-0675-2025 | 09-15-2025 | Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) Package NDCs: 60687-583-11; 60687-583-21; 60687-594-11; 60687-594-21 | Failed Dissolution Specifications. | Amerisource Health Services LLC / 360 cartons | Class II | Ongoing |
| D-0037-2026 | 09-15-2025 | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. Package NDCs: 16571-862-03; 16571-862-09; 16571-862-50; 16571-862-10; 16571-862-12; 16571-863-03; 16571-863-09; 16571-863-50; 16571-863-10 | Failed Tablet/Capsule Specifications | Graviti Pharmaceuticals Private Limited / 46,512/30 count bottles | Class II | Ongoing |
| D-0009-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 2064 blister packs | Class II | Ongoing |
| D-0012-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 866 blister packs | Class II | Ongoing |
| D-0011-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 506 blister packs | Class II | Ongoing |
| D-0013-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1394 blister packs | Class II | Ongoing |
| D-0033-2026 | 09-12-2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50 Package NDCs: 16571-402-10; 16571-402-30; 16571-402-50 | Tablet/Capsules Imprinted with Wrong ID | JB Chemicals and Pharmaceuticals Ltd / 13,440 bottles | Class III | Ongoing |
| D-0032-2026 | 09-12-2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10. Package NDCs: 16571-402-10; 16571-402-30; 16571-402-50 | Tablet/Capsules Imprinted with Wrong ID | JB Chemicals and Pharmaceuticals Ltd / 9936 bottles | Class III | Ongoing |
| D-0138-2026 | 09-12-2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 | Labeling: Not Elsewhere Classified | Letco Medical LLC / 173 500 ml bottles | Class III | Ongoing |
| D-0010-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1256 blister packs | Class II | Ongoing |
| D-0666-2025 | 09-12-2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0664-2025 | 09-12-2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0665-2025 | 09-12-2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0663-2025 | 09-12-2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / 125 | Class II | Ongoing |
| D-0668-2025 | 09-12-2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ. | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0667-2025 | 09-12-2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825. | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0026-2026 | 09-05-2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 1,041 cartons | Class III | Ongoing |
| D-0677-2025 | 09-05-2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. Package NDCs: 60505-1003-1; 60505-1003-2; 6050510031; 3605051003 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. / 493,468 bottles | Class II | Ongoing |
| D-0676-2025 | 09-05-2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL). Package NDCs: 60505-0589-1; 60505-0589-2; 60505-0589-3; 0036050505; 6050505892 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. / 151,034 bottles | Class II | Ongoing |
| D-0651-2025 | 09-05-2025 | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10. Package NDCs: 0781-3528-75; 0781-3528-10; 0781-3529-70; 0781-3529-10; 0781-3530-80; 0781-3530-10; 0030781352; 1068604062; 1068728143; 1068740996; 1070120033; 1068732564; 1068766116 | cGMP deviations: Temperature excursion during transportation. | Sandoz Inc / 6 vials | Class II | Ongoing |
| D-0656-2025 | 09-04-2025 | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 4344 bottles | Class II | Ongoing |
| D-0657-2025 | 09-04-2025 | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 4440 bottles | Class II | Ongoing |
| D-0637-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0636-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0639-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0658-2025 | 09-03-2025 | Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1 Package NDCs: 45567-0655-1 | Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. | SUN PHARMACEUTICAL INDUSTRIES INC / 1870 kits | Class II | Ongoing |
| D-0630-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0635-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0633-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0634-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0632-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0631-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0638-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0021-2026 | 09-03-2025 | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29. Package NDCs: 68462-318-84; 68462-318-29 | Failed Impurities/Degradation Specifications | Glenmark Pharmaceuticals Inc., USA / 26,928 packs | Class II | Ongoing |
| D-0625-2025 | 09-02-2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters). Package NDCs: 55154-7895-0; 0904-2725-61 | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Ongoing |
| D-0624-2025 | 09-02-2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61 Package NDCs: 0904-2725-61 | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Ongoing |
| D-0007-2026 | 09-02-2025 | Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28 Package NDCs: 42291-565-28; 42291-565-84 | Failed Content Uniformity Specifications | AvKARE / 2192 cartons | Class II | Ongoing |
| D-0646-2025 | 08-29-2025 | bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226 | Lack of Assurance of Sterility | Fagron Compounding Services / 109,320 syringes | Class II | Ongoing |
| D-0304-2026 | 08-28-2025 | Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil | Green Lumber Holdings, LLC / N/A | Class I | Ongoing |
| D-0671-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 9,917 bottles | Class III | Ongoing |
| D-0673-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 11,928 bottles | Class III | Ongoing |
| D-0669-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 3,384 bottles | Class III | Ongoing |
| D-0670-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 11,895 bottles | Class III | Ongoing |
| D-0672-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 11,909 bottles | Class III | Ongoing |
| D-0645-2025 | 08-28-2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03 Package NDCs: 67877-431-03; 67877-431-01; 67877-431-05; 67877-431-33; 67877-431-38; 67877-431-32; 67877-432-03; 67877-432-01; 67877-432-05; 67877-432-33; 67877-432-38; 67877-432-32; 67877-433-03; 67877-433-01; 67877-433-05; 67877-433-33; 67877-433-38; 67877-433-32; 67877-434-03; 67877-434-01; 67877-434-05; 67877-434-33; 67877-434-38; 67877-435-03; 67877-435-01; 67877-435-05; 67877-435-33; 67877-435-38; 67877-430-03; 67877-430-01; 67877-430-05; 67877-430-33; 67877-430-38; 67877-430-32 | Superpotent drug | Ascend Laboratories, LLC / 2,256 bottles | Class II | Ongoing |
| D-0623-2025 | 08-27-2025 | Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton). Package NDCs: 70710-1377-1; 70710-1377-2 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. | Zydus Pharmaceuticals (USA) Inc / 270,125 Vials | Class II | Ongoing |
| D-0629-2025 | 08-27-2025 | Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01 | cGMP violations | Atlantic Management Resources Ltd. / 72 containers | Class II | Ongoing |
| D-0655-2025 | 08-27-2025 | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19. Package NDCs: 29300-413-05; 29300-413-10; 29300-413-01; 29300-413-19; 29300-414-01; 29300-414-10; 29300-415-01; 29300-415-05; 29300-415-10; 29300-415-19 | Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). | Unichem Pharmaceuticals USA Inc. / 230 90-count bottles | Class I | Ongoing |
| D-0648-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11) Package NDCs: 60687-419-11; 60687-419-01; 60687-430-11; 60687-430-01; 60687-430-65; 60687-441-11; 60687-441-01; 60687-452-11; 60687-452-01; 60687-463-11; 60687-463-01 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 1,062 cartons | Class II | Ongoing |
| D-0649-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11) Package NDCs: 60687-419-11; 60687-419-01; 60687-430-11; 60687-430-01; 60687-430-65; 60687-441-11; 60687-441-01; 60687-452-11; 60687-452-01; 60687-463-11; 60687-463-01 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 1,757 cartons | Class II | Ongoing |
| D-0650-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11) Package NDCs: 60687-419-11; 60687-419-01; 60687-430-11; 60687-430-01; 60687-430-65; 60687-441-11; 60687-441-01; 60687-452-11; 60687-452-01; 60687-463-11; 60687-463-01 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 873 cartons | Class II | Ongoing |
| D-0167-2026 | 08-27-2025 | Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 576 containers | Class II | Ongoing |
| D-0164-2026 | 08-27-2025 | DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 2,673 tubes | Class II | Ongoing |
| D-0647-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Package NDCs: 60687-419-11; 60687-419-01; 60687-430-11; 60687-430-01; 60687-430-65; 60687-441-11; 60687-441-01; 60687-452-11; 60687-452-01; 60687-463-11; 60687-463-01 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 2,708 cartons | Class II | Ongoing |
| D-0168-2026 | 08-27-2025 | KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 15,267 cartridges | Class II | Ongoing |
| D-0176-2026 | 08-27-2025 | San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 15,465 cartridges | Class II | Ongoing |
| D-0166-2026 | 08-27-2025 | GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 115,994 containers | Class II | Ongoing |
