Browse Drug Recalls

629 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 629 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 629 FDA drug recalls in OH.

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DateProductReasonClassFirm
Jun 21, 2013 Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Aceta... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. ... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl o... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl ... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 14, 2013 Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablet... Labeling: Missing Label; missing label on blister card Class III Boehringer Ingelheim Roxane Inc
May 21, 2013 Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carto... Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which cou... Class II American Health Packaging
Apr 3, 2013 Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringe... Resuspension Problems: Recalled lot did not meet resuspendability requirements. Class II Boehringer Ingelheim Roxane Inc
Mar 18, 2013 Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets... SubPotent Drug: The firm discovered out of specification results for assay and the extended inves... Class III Boehringer Ingelheim Roxane Inc
Feb 4, 2013 buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... Failed Stability Specifications; out of specification results at the 9 month stability time point... Class III American Health Packaging
Dec 12, 2012 Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringe... Impurities/Degradation Products: Out of Specification results found for impurity B, identified as... Class III Boehringer Ingelheim Roxane Inc
Nov 8, 2012 Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor ... Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the wa... Class II Procter & Gamble Co
Nov 5, 2012 Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Di... Defective container; damaged bottles could allow moisture to get into the bottle and thus may imp... Class II Boehringer Ingelheim Roxane Inc
Oct 10, 2012 QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packa... Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months ... Class II American Health Packaging
Jul 27, 2012 Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 f... Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkh... Class III Natural Essentials Inc
Jul 25, 2012 Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, R... Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly... Class III American Health Packaging
Jul 23, 2012 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... Class II American Health Packaging
Jul 5, 2012 Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, M... Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline... Class II Ben Venue Laboratories Inc
Jun 26, 2012 Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg... Presence of Particulate Matter Class I Ben Venue Laboratories Inc
May 21, 2012 Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distri... Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the ... Class II Kutol Products Co Inc
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
May 1, 2012 Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 m... Short Fill: These products are being recalled because there is potential that vials with low fill... Class II Ben Venue Laboratories Inc
May 1, 2012 Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials,... Short Fill: These products are being recalled because there is potential that vials with low fill... Class II Ben Venue Laboratories Inc
Sep 27, 2011 Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to cont... Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexo... Class II Shamrock Medical Solutions Group LLC
Sep 27, 2011 Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx... Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400... Class II Shamrock Medical Solutions Group LLC
Sep 27, 2011 Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiam... Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules Class I Shamrock Medical Solutions Group LLC
Sep 27, 2011 Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as M... Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE... Class I Shamrock Medical Solutions Group LLC
Sep 27, 2011 Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta... Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calc... Class II Shamrock Medical Solutions Group LLC
Sep 27, 2011 metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate... Labeling: Label Mix up; product labeled did not indicated Extended Release Class I Shamrock Medical Solutions Group LLC

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.