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Browse Drug Recalls

151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 151 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 151 FDA drug recalls.

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DateProductReasonClassFirm
Apr 26, 2021 Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Mar 15, 2021 EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (A... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister C... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by:... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 4, 2021 Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... Class III Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-do... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-D... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL,... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), pa... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Aug 24, 2020 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... Sub-Potent Drug: Out of specification test results for potency (below specification). Class II Teva Pharmaceuticals USA
Aug 24, 2020 Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For ... CGMP deviations; there is a possibility that some bottles in these lots may have the active ingre... Class II Teva Pharmaceuticals USA
Aug 24, 2020 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... CGMP deviations; there is a possibility that some bottles in these lots may have the active ingre... Class II Teva Pharmaceuticals USA
May 22, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Some bottles may contain mixed strengths of the product. Class II Teva Pharmaceuticals USA
May 22, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Some bottles may contain mixed strengths of the product. Class II Teva Pharmaceuticals USA
May 22, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Some bottles may contain mixed strengths of the product. Class II Teva Pharmaceuticals USA
Mar 5, 2020 Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled ... CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-market... Class II Teva Pharmaceuticals USA
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 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 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
Nov 4, 2019 Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... Presence of foreign substance: Brown/black particles found during stability testing. Class II Teva Pharmaceuticals USA, Inc.
Apr 12, 2019 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL ... Subpotent Product: assay results for Amoxicillin were below the specification limits. Class II Teva Pharmaceuticals USA
Mar 11, 2019 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablet... Subpotent Drug. Class III Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Sep 27, 2018 Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per... Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... Class II Teva Pharmaceuticals USA
Sep 21, 2018 Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... Class II Teva Pharmaceuticals USA
Sep 20, 2018 Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... Failed Stability Specifications: Out-of-specification test result for water content obtained duri... Class II Teva Pharmaceuticals USA
Feb 5, 2018 Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... Class III Teva Pharmaceuticals USA
Dec 14, 2017 Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg,... Failed Impurities/Degradation Specifications: High out of specification test result for the Moexi... Class II Teva Pharmaceuticals USA
Nov 28, 2017 Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 1... Failed Impurities/Degradation Specifications: high out of specification test results obtained for... Class III Teva Pharmaceuticals USA
Jun 29, 2017 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle... Failed Impurities/Degradation Specifications: out of specification test results for related comp... Class III Teva Pharmaceuticals USA
Jun 29, 2017 Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bot... Failed Impurities/Degradation Specifications: out of specification test results for related comp... Class III Teva Pharmaceuticals USA

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.