Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 24, 2020 | Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 241... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 20, 2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... | Failed Dissolution Specifications: Low out of specification dissolution result observed during st... | Class II | Teva Pharmaceuticals USA |
| Feb 19, 2020 | Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, R... | Failed Impurities/Degradation Specification; high out of specification results observed | Class II | Lupin Pharmaceuticals Inc. |
| Feb 12, 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... | Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... | Class II | Lupin Pharmaceuticals 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 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 | 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 | 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 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 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 | 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 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 | Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone... | 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 | Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-d... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrig... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Mult... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML]... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/M... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 25... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABL... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Us... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG... | 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.