Browse Drug Recalls
522 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 522 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 522 FDA drug recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2026 | Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx o... | Failed dissolution specifications. | Class III | Supernus Pharmaceuticals, Inc. |
| Aug 26, 2026 | Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile,... | Failed Dissolution Specifications | Class II | Mylan Pharmaceuticals Inc |
| Aug 24, 2026 | traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactur... | Presence of Foreign Tablets/Capsules | Class II | Teva Pharmaceuticals USA, Inc |
| Aug 24, 2026 | Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) ... | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclo... | Class II | Hikma Pharmaceuticals USA INC. |
| Aug 21, 2026 | Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (C... | CGMP Deviations: Potential contamination of raw material | Class II | Lexia LLC |
| Aug 21, 2026 | Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Iso... | CGMP Deviations: Potential contamination of raw material | Class II | Lexia LLC |
| Aug 14, 2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... | Class II | Allies Group Inc. |
| Aug 14, 2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... | Class II | Allies Group Inc. |
| Aug 14, 2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... | Class II | Allies Group Inc. |
| Aug 14, 2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... | Class II | Allies Group Inc. |
| Aug 13, 2026 | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx o... | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance c... | Class II | Apotex Corp. |
| Aug 12, 2026 | Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. ... | Presence of Particulate matter. | Class I | B BRAUN MEDICAL INC |
| Aug 10, 2026 | Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx ... | Presence of particulate matter:An internal investigation at the firm found the product to contain... | Class I | Fresenius Kabi USA, LLC |
| Aug 10, 2026 | Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus,... | CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for micro... | Class II | Church & Dwight Co., Inc. |
| Aug 7, 2026 | Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, ... | Presence of Foreign Tablets/Capsules | Class III | Bionpharma Inc. |
| Aug 7, 2026 | Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 5140... | CGMP deviations: tablets with black specks. | Class II | Golden State Medical Supply Inc. |
| Aug 6, 2026 | Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY ... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY ... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 unit... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) i... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Sin... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL ... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY ... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per ... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALA... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose C... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 5... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/m... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL)... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 unit... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALA... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-coun... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx ... | Presence of particulate matter: glass and stopper piece | Class II | Mallinckrodt Hospital Products Inc. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Onl... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-coun... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx O... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 5, 2026 | Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufac... | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 4, 2026 | Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefille... | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of ... | Class I | Fresenius Kabi USA, LLC |
| Aug 4, 2026 | Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manu... | Failed Dissolution Specifications | Class II | Novartis Pharmaceuticals Corporation |
| Aug 3, 2026 | Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured ... | CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing | Class II | SUN PHARMACEUTICAL INDUSTRIES 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.