Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Jan 30, 2013 BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, I... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Dis... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufac... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 22, 2013 Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg... CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturin... Class II RX South LLC DBA RX3 Pharmacy
Nov 2, 2012 ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, ... CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not se... Class II Bristol Myers Squibb Manufacturing Company
Sep 28, 2012 Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... CGMP Deviations: The products were manufactured with raw material which contain unknown particles... Class III ITW Dymon
Sep 6, 2012 Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, ... CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substitu... Class II Church & Dwight Inc
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, ... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, ... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, ... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jun 21, 2012 OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 6... CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation Class II Oklahoma Respiratory Care Inc
Jun 21, 2012 Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, ... CGMP Deviations: Shipment of product not approved for release. Class III Hospira, Inc.
May 25, 2012 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... CGMP Deviations: This product is being recalled because expired flavoring was used in the manufac... Class II Mallinckrodt Inc.
May 14, 2012 Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial ... CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have app... Class II Abbott Laboratories
May 4, 2012 LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration ... Class II Linde Gas LLC
Feb 6, 2012 Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for:... CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w... Class II sanofi-aventis US, Inc.
Feb 6, 2012 Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. fo... CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w... Class II sanofi-aventis US, Inc.
Jun 15, 2011 Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere... CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. Class III Apotex Corp.

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.