Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERIL... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBC... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 13, 2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg... | Subpotent drug; Clavulanate Potassium component | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 10, 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottl... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx on... | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... | Class III | Alembic Pharmaceuticals Limited |
| Oct 10, 2025 | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips w... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) p... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Trometha... | Presence of Particulate Matter | Class II | QuVa Pharma, Inc. |
| Oct 10, 2025 | Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Ar... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx on... | Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... | Class II | The Harvard Drug Group LLC |
| Oct 10, 2025 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips ... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Dis... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... | Lack of Assurance of Sterility. | Class II | Samsung Bioepis Co., Ltd. |
| Oct 10, 2025 | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips w... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only,... | Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... | Class II | The Harvard Drug Group LLC |
| Oct 10, 2025 | Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottl... | Failed Dissolution Specifications | Class II | Lannett Company Inc. |
| Oct 10, 2025 | Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile,... | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. | Class II | Safecor Health, LLC |
| Oct 10, 2025 | Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 9, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51... | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Class II | Breckenridge Pharmaceutical, Inc. |
| Oct 9, 2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... | Class II | Amerisource Health Services LLC |
| Oct 9, 2025 | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bo... | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity... | Class II | USV Private Limited |
| Oct 9, 2025 | Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Techn... | Marketed Without an Approved NDA/ANDA | Class II | ibspot |
| Oct 9, 2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 8, 2025 | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syring... | Lack of Assurance of Sterility: | Class II | ASTRAZENECA PHARMACEUTICALS |
| Oct 8, 2025 | Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Dist... | Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsul... | Class I | Mohamed Hagar |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottl... | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, ... | Class II | Rising Pharma Holding, Inc. |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus... | Discoloration | Class II | VIONA PHARMACEUTICALS INC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.