Total records
16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Most recent report
September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
Sorted by most recent report date.
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Page 8 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0471-2025 | Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10 | Aurobindo Pharma USA Inc | Ongoing | Class II | Jun 25, 2025 |
| D-0472-2025 | 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 | Eugia US LLC | Ongoing | Class II | Jun 25, 2025 |
| D-0492-2025 | 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 | Umary-USA.com | Ongoing | Class I | Jun 25, 2025 |
| D-0493-2025 | UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134 | Umary-USA.com | Ongoing | Class I | Jun 25, 2025 |
| D-0459-2025 | 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 | Alembic Pharmaceuticals Limited | Ongoing | Class II | Jun 18, 2025 |
| D-0497-2025 | 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. | Zydus Pharmaceuticals (USA) Inc | Ongoing | Class II | Jun 18, 2025 |
| D-0462-2025 | 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 | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class III | Jun 18, 2025 |
| D-0464-2025 | MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3. | SAINI TRADE INC | Ongoing | Class I | Jun 18, 2025 |
| D-0469-2025 | 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 | Ascend Laboratories, LLC | Ongoing | Class II | Jun 18, 2025 |
| D-0468-2025 | 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 | Ascend Laboratories, LLC | Ongoing | Class II | Jun 18, 2025 |
| D-0460-2025 | Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 | AvKARE | Ongoing | Class II | Jun 18, 2025 |
| D-0465-2025 | ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J. | SAINI TRADE INC | Ongoing | Class I | Jun 18, 2025 |
| D-0466-2025 | ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9. | SAINI TRADE INC | Ongoing | Class I | Jun 18, 2025 |
| D-0463-2025 | Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG. | SAINI TRADE INC | Ongoing | Class I | Jun 18, 2025 |
| D-0470-2025 | 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. | Macleods Pharmaceuticals Ltd | Ongoing | Class III | Jun 18, 2025 |
| D-0467-2025 | Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH. | SAINI TRADE INC | Ongoing | Class I | Jun 18, 2025 |
| D-0461-2025 | 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 | AvKARE | Ongoing | Class II | Jun 18, 2025 |
| D-0454-2025 | 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). | Amerisource Health Services LLC | Ongoing | Class II | Jun 11, 2025 |
| D-0456-2025 | 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) | Torrent Pharma Inc. | Ongoing | Class II | Jun 11, 2025 |
| D-0455-2025 | 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 | Torrent Pharma Inc. | Ongoing | Class II | Jun 11, 2025 |
| D-0457-2025 | 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 | Apotex Corp. | Ongoing | Class II | Jun 11, 2025 |
| D-0458-2025 | 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 | Consumer Product Partners, LLC | Ongoing | Class II | Jun 11, 2025 |
| D-0450-2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05 | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Jun 4, 2025 |
| D-0448-2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Jun 4, 2025 |
| D-0451-2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Jun 4, 2025 |