Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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DateProductReasonClassFirm
Feb 24, 2020 Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... Class III Breckenridge Pharmaceutical, Inc
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 24, 2020 Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redl... Lack Of Processing Controls Class II Redline Pharmacy Solutions
Feb 24, 2020 Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, ... Lack Of Processing Controls Class II Redline Pharmacy Solutions
Feb 24, 2020 Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Sp... Lack Of Processing Controls Class II Redline Pharmacy Solutions
Feb 24, 2020 Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty... Lack Of Processing Controls Class II Redline Pharmacy Solutions
Feb 24, 2020 Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, ... Lack Of Processing Controls Class II Redline Pharmacy Solutions
Feb 21, 2020 Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 21, 2020 CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 21, 2020 Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, D... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
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 17, 2020 Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count b... Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chlor... Class III Strides Pharma Science Limited
Feb 14, 2020 Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m... Labeling: Incorrect or Missing Lot and/or Expiration date. Class III AAA Pharmaceutical, Inc.
Feb 12, 2020 TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC ... Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... Class III Golden State Medical Supply 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 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 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 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 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 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 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 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 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 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
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
Jan 31, 2020 Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... cGMP Deviations Class II Zydus Pharmaceuticals USA 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 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 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 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 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 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 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 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 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, 0.2 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), 27 mg, 100-c... CGMP deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 27, 2020 Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured... GMP Deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 24, 2020 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 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 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 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 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 Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-3... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Direct Rx
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 Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC... 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.