Browse Drug Recalls
138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 138 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 138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 17, 2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications: low out of specification dissolution results found during stab... | Class III | Teva Pharmaceuticals USA |
| Feb 7, 2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottle... | Failed Impurities/Degradation Specifications | Class II | Teva Pharmaceuticals USA |
| Dec 1, 2016 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications | Class III | Teva Pharmaceuticals USA |
| Sep 22, 2016 | PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pha... | Failed Impurities/Degradation Specifications: out of specification test results for impurities du... | Class III | Teva Pharmaceuticals USA |
| Sep 22, 2016 | PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pha... | Failed Impurities/Degradation Specifications: out of specification test results for impurities du... | Class III | Teva Pharmaceuticals USA |
| Sep 22, 2016 | PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pha... | Failed Impurities/Degradation Specifications: out of specification test results for impurities du... | Class III | Teva Pharmaceuticals USA |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured ... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufacture... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jun 17, 2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... | CGMP Deviations | Class II | Teva North America |
| May 18, 2016 | Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,... | Failed Tablet/Capsule Specifications | Class III | Teva North America |
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.