Browse Drug Recalls

158 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 158 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 158 FDA drug recalls.

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Date	Product	Reason	Class	Firm
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
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
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
Nov 26, 2013	Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva ...	Failed Tablet/Capsule Specifications: There is a potential for broken tablets.	Class II	Teva Pharmaceuticals USA
Nov 14, 2013	Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, L...	Failed Stability Specifications: this product is below specification for preservative content.	Class III	Teva Pharmaceuticals USA, Inc.
Nov 8, 2013	Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufacture...	Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Val...	Class II	Teva Pharmaceuticals USA, Inc.
Oct 24, 2013	Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe,...	Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported thr...	Class II	Teva Pharmaceuticals USA
Aug 13, 2013	CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medic...	Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual...	Class II	Teva Pharmaceuticals USA, Inc.
Aug 6, 2013	Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, ...	Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10...	Class II	Teva Pharmaceuticals USA, Inc.
Jul 23, 2013	Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactur...	Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (H...	Class II	Teva Pharmaceuticals USA, Inc.
Jun 18, 2013	Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-41...	Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin...	Class III	Teva Pharmaceuticals USA, Inc.
Jun 18, 2013	Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 coun...	Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut...	Class II	Teva Pharmaceuticals USA, Inc.
Jun 18, 2013	Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 coun...	Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut...	Class II	Teva Pharmaceuticals USA, Inc.
Jun 18, 2013	Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 coun...	Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut...	Class II	Teva Pharmaceuticals USA, Inc.
May 28, 2013	Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Sin...	Failed Dissolution Specification; during stability testing	Class II	Teva Pharmaceuticals USA, Inc.
Apr 26, 2013	Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0...	Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin p...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 19, 2013	Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for T...	CGMP Deviation; cotton coil is missing in some packaged bottles	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 m...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 9...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 ...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 t...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 14, 2013	Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and E...	Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 14, 2013	Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 e...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 12, 2013	Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, ...	Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specifica...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 12, 2013	Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count...	Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specifica...	Class III	Teva Pharmaceuticals USA, Inc.
Feb 26, 2013	Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0...	Defective Container: This recall is being carried out due to the potential for improperly sealed ...	Class II	Teva Pharmaceuticals USA, Inc.
Feb 7, 2013	CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blist...	Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specificat...	Class II	Teva Pharmaceuticals USA, Inc.

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.