Browse Drug Recalls

607 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 607 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 607 FDA drug recalls in OH.

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DateProductReasonClassFirm
Jul 28, 2014 OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Class III Boehringer Ingelheim Roxane Inc
Jul 1, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jul 1, 2014 Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
May 1, 2014 Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at... Class II Boehringer Ingelheim Roxane Inc
Apr 4, 2014 Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... Class III Boehringer Ingelheim Roxane Inc
Apr 4, 2014 Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... Class III Boehringer Ingelheim Roxane Inc
Mar 27, 2014 Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spi... Defective Delivery System: Potential for dose delivery out of specification due to interation of ... Class III Boehringer Ingelheim Roxane Inc
Feb 14, 2014 Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratorie... Presence of Particulate Matter: During a review of retain samples, the firm found a glass particu... Class I Ben Venue Laboratories Inc
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Oct 2, 2013 Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... Class III Cardinal Health
Aug 30, 2013 SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per... Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic ... Class III Boehringer Ingelheim Roxane Inc
Aug 29, 2013 Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen ... Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped w... Class II Procter & Gamble Co
Aug 2, 2013 Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only,... Subpotent Class II American Health Packaging
Jul 3, 2013 DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HC... Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomp... Class II Procter & Gamble Co
Jun 21, 2013 I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcoh... 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 sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, 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 GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 Share a Smile Mixed berry Anti bac Justice, 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 I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 f... 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 to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 Shine from within blueberry Anti bac Justice, 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 Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net ... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
Jun 21, 2013 LIFE IS SWEET! Justice, Vanilla Scent 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 21, 2013 TODAY IS AWESOME! Justice, Cotton Candy 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 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

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.