Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 8, 2026 | MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufac... | cGMP Deviations | Class II | SHANTOU Qiwei industrial Co., Ltd |
| 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 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 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 |
| Aug 3, 2026 | TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compoundi... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compo... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compoun... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescriptio... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Jul 23, 2026 | Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distribu... | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactur... | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Class II | Cipla USA, Inc. |
| Jun 29, 2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactur... | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Class II | Cipla USA, Inc. |
| Jun 29, 2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactur... | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Class II | Cipla USA, Inc. |
| Jun 23, 2026 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... | CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 22, 2026 | DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Direct Rx |
| Jun 12, 2026 | Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-relea... | CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed... | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Jun 4, 2026 | Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed b... | CGMP Deviations | Class II | Amgen, Inc. |
| Jun 4, 2026 | Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed b... | CGMP Deviations | Class II | Amgen, Inc. |
| Jun 4, 2026 | Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed b... | CGMP Deviations | Class II | Amgen, Inc. |
| Jun 4, 2026 | Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jun 4, 2026 | Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (N... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jun 2, 2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin S... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Su... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufacture... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neom... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactur... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured f... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
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.