Browse Drug Recalls

305 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 305 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 305 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Mar 4, 2014	Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bot...	Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain ...	Class II	Teva Pharmaceuticals USA
Mar 4, 2014	Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bot...	Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain ...	Class II	Teva Pharmaceuticals USA
Mar 4, 2014	Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bot...	Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain ...	Class II	Teva Pharmaceuticals USA
Mar 3, 2014	Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ...	Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.	Class III	McKesson Packaging Services
Feb 14, 2014	Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: W...	Chemical Contamination: The recalling firm received notice that their supplier is recalling capsu...	Class II	Legacy Pharmaceutical Packaging
Feb 12, 2014	Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in P...	Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.	Class II	Teva Pharmaceuticals USA
Feb 12, 2014	Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-6...	Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.	Class II	Teva Pharmaceuticals USA
Feb 11, 2014	QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cy...	Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point	Class III	Teva Pharmaceuticals USA
Jan 24, 2014	Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Dis...	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved m...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Onl...	CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Su...	CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate an...	Class II	Teva Pharmaceuticals USA
Jan 24, 2014	Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Di...	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved ...	Class II	Teva Pharmaceuticals USA
Dec 18, 2013	Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Man...	Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of sp...	Class II	Teva Pharmaceuticals USA
Dec 18, 2013	Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured...	Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of sp...	Class II	Teva Pharmaceuticals USA
Dec 4, 2013	Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 mete...	Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aer...	Class III	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
Oct 11, 2013	Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose ...	Presence of Precipitate; precipitation of drug product	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 18, 2013	Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care,...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Physicians Total Care, 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.
Feb 1, 2013	TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti...	Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre...	Class III	Ferring Pharmaceuticals Inc
Jan 23, 2013	Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC...	Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in...	Class II	Teva Pharmaceuticals USA, Inc.
Dec 5, 2012	Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single us...	Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of p...	Class II	Teva Pharmaceuticals USA, Inc.
May 18, 2012	Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed b...	Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particl...	Class II	Teva Pharmaceuticals USA, Inc.
May 16, 2012	Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactur...	Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and o...	Class II	Teva Pharmaceuticals USA, Inc.
May 2, 2012	Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0....	Impurities/Degradation: This recall is being carried out due to the potential for some lots not ...	Class II	Teva Pharmaceuticals USA, Inc.
Apr 24, 2012	CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA...	Impurities/Degradation Products: This lot of product will not meet the impurity specification ove...	Class III	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.