Browse Drug Recalls
310 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 310 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 310 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 28, 2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... | Failed Stability Specifications | 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 |
| Feb 2, 2017 | Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 2... | Failed Impurities/Degradation Specifications: out of specification test results for the norethin... | Class II | Teva Pharmaceuticals USA |
| Dec 21, 2016 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... | Subpotency: due to a low, out of specification test result for assay during stability testing. | 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 |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | 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 |
| Sep 13, 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... | Failed Impurities/Degradation Specifications: potential failure to meet the specification for Imp... | Class III | Teva Pharmaceuticals USA |
| Aug 5, 2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 ... | Failed Impurities/Degradation Specifications. | Class III | Teva North America |
| 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 22, 2016 | Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in ... | Presence of Foreign Substance; presence of black particles describes generically as cellulose-bas... | Class II | Teva North America |
| 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 |
| Apr 27, 2016 | Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-3... | Lack of Assurance of Sterility: Due to potential for leaking bags. | Class II | Teva North America |
| Mar 25, 2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle... | Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta... | Class III | Bryant Ranch Prepack Inc. |
| Mar 9, 2016 | Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manu... | Presence of Particulate Matter: particulate matter identified as glass in one vial. | Class I | Teva Pharmaceuticals USA |
| Feb 5, 2016 | Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By... | Failed Impurities/Degradation Specifications: Out of specification test results for impurities du... | Class II | Teva Pharmaceuticals USA |
| Dec 21, 2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... | Failed Dissolution Specifications: low test results at the 18 month time-point | Class II | Teva North America |
| Nov 19, 2015 | NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri... | Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. | Class III | Teva Pharmaceuticals USA |
| Nov 12, 2015 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... | Failed Impurities/Degradation Specifications: High out of specification test result for impuritie... | Class II | Teva Pharmaceuticals USA |
| Sep 10, 2015 | ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays... | Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. | Class III | EMD Serono, Inc. |
| Jul 24, 2015 | ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x... | Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution | Class I | Teva Pharmaceuticals USA |
| Jun 24, 2015 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: out of specification for unknown impurity | Class II | Teva Pharmaceuticals USA |
| May 11, 2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: OOS result during stability testing | Class II | Teva Pharmaceuticals USA |
| May 7, 2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For... | Failed Impurities/Degradation Specifications: out of specification test results for an impurity d... | Class III | Teva Pharmaceuticals USA |
| Apr 28, 2015 | Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct In... | Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone ... | Class I | Teva Pharmaceuticals USA |
| Apr 17, 2015 | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time po... | Class II | Valeant Pharmaceuticals North America LLC |
| Apr 13, 2015 | Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured b... | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... | Class II | Teva Pharmaceuticals USA |
| Apr 13, 2015 | Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-6... | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... | Class II | Teva Pharmaceuticals USA |
| Oct 8, 2014 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... | Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. | Class II | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 ... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyc... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 5, 2014 | Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, ... | Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets... | Class II | Teva Pharmaceuticals USA |
| May 29, 2014 | Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for T... | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one... | Class II | Teva Pharmaceuticals USA |
| May 1, 2014 | Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Ba... | Failed Impurities/Degradation Specifications: this product is being recalled due to an out of spe... | Class II | Teva Pharmaceuticals USA |
| Apr 28, 2014 | TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bott... | Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone ... | Class II | Ferring Pharmaceuticals Inc |
| Apr 23, 2014 | QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered... | Defective Delivery System; defective valve | Class II | Teva Pharmaceuticals USA |
| Apr 7, 2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... | Class II | Teva Pharmaceuticals USA |
| Apr 7, 2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... | Class II | Teva Pharmaceuticals USA |
| Apr 1, 2014 | triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP... | Failed Impurities/Degradation Specifications: This recall is due to out of specification for impu... | Class II | 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.