Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2020 | Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... | Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio... | Class III | Par Pharmaceutical Inc. |
| Feb 7, 2020 | Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose... | Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found ... | Class III | AuroMedics Pharma LLC |
| Feb 7, 2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Feb 7, 2020 | Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister ca... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | American Health Packaging |
| Feb 7, 2020 | Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister ca... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | American Health Packaging |
| Feb 7, 2020 | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count b... | Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cabl... | Class II | AuroMedics Pharma LLC |
| Feb 5, 2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-c... | Defective Container: products potentially could have been packaged in defective bottles, with a n... | Class II | Pfizer Inc. |
| Feb 5, 2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-c... | Defective Container: products potentially could have been packaged in defective bottles, with a n... | Class II | Pfizer Inc. |
| Feb 3, 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... | Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... | Class II | Pfizer Inc. |
| Feb 3, 2020 | Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduce... | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... | Class II | Contract Pharmacal Corporation |
| Feb 3, 2020 | Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduc... | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... | Class II | Contract Pharmacal Corporation |
| Jan 31, 2020 | New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Jan 31, 2020 | Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Effici... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Jan 31, 2020 | Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed b... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Jan 31, 2020 | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... | cGMP Deviations | Class II | Zydus Pharmaceuticals USA Inc |
| Jan 29, 2020 | Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa... | Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure... | Class III | UNICHEM PHARMACEUTICALS USA INC |
| Jan 28, 2020 | Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUT... | Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unk... | Class II | NCS Healthcare of Kentucky Inc |
| Jan 28, 2020 | Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottl... | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... | Class III | Teva Pharmaceuticals USA |
| Jan 28, 2020 | Kushim Tablets (Gushim) 45-count packages, Label in foreign language | Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin... | Class II | B AND A TRADING CORPORATION |
| Jan 28, 2020 | Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufact... | Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tabl... | Class II | Graviti Pharmaceuticals Private Limited |
| Jan 27, 2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-c... | CGMP deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 27, 2020 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 27, 2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-c... | CGMP deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 27, 2020 | Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 24, 2020 | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactu... | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API sour... | Class II | Ascend Laboratories LLC |
| Jan 24, 2020 | Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51... | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... | Class II | Breckenridge Pharmaceutical, Inc |
| Jan 24, 2020 | Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 5199... | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... | Class II | Breckenridge Pharmaceutical, Inc |
| Jan 24, 2020 | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, ... | Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitaz... | Class III | Macleods Pharma Usa Inc |
| Jan 22, 2020 | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... | Failed Dissolution Specifications: low out of specification results for dissolution testing. | Class III | Ascend Laboratories LLC |
| Jan 20, 2020 | Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... | Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... | Class III | Macleods Pharma Usa Inc |
| Jan 16, 2020 | Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 ba... | Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturi... | Class II | Shandex Personal Care Manufacturing Inc. |
| Jan 15, 2020 | Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTAB... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, M... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIA... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Sh... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use,... | Lack of Assurance of Sterility | Class III | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCL... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, M... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
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.