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
Sep 25, 2017 methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... Class II RXQ Compounding LLC
Aug 29, 2017 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... Failed Stability Specifications Class III Amerisource Health Services
Apr 4, 2017 Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by ... Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with ill... Class III West-Ward Columbus, Inc.
Feb 8, 2017 CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, ... Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... Class II Amerisource Health Services
Feb 3, 2017 GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21... Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... Class II Amerisource Health Services
Dec 22, 2016 Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratori... Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. Class II Roxane Laboratories, Inc.
Dec 14, 2016 Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spra... Defective Delivery System: out of specification result for droplet size distribution at the d90 m... Class III Roxane Laboratories, Inc.
Oct 27, 2016 Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... Class III Amerisource Health Services
Oct 13, 2016 AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Indi... Presence of Foreign Tablets/Capsules Class III Amerisource Health Services
Oct 3, 2016 PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-War... Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. Class II West-Ward Pharmaceutical
Sep 30, 2016 Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC... Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufac... Class III Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 4, 2016 buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count ... Failed dissolution specifications - the out of specification result for dissolution was identifie... Class III Amerisource Health Services
May 23, 2016 Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY T... Failed Dissolution Specifications Class II Nostrum Laboratories, Inc.
May 19, 2016 Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehring... Failed Impurities/Degradation Specification; 9 month stability Class III West-Ward Columbus Inc
May 11, 2016 tabcin NOCHE; Capsules,12-count box, UPC 501008485033 CGMP Deviations Class II Profarma Distributors LLC
May 11, 2016 VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 CGMP Deviations Class II Profarma Distributors LLC
May 11, 2016 tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 CGMP Deviations Class II Profarma Distributors LLC
May 11, 2016 VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 CGMP Deviations Class II Profarma Distributors LLC
May 11, 2016 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 CGMP Deviations Class II Profarma Distributors LLC
Mar 31, 2016 Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Mar 31, 2016 Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Jan 26, 2016 Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Di... Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Class III Amerisource Health Services
Jan 18, 2016 Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister car... Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Class II Amerisource Health Services
Dec 15, 2015 ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E.... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Soluti... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Heal... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu ... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N O... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceu... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Nov 29, 2015 Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, In... cGMP Deviations; trailer may not have met GMP requirements prior to filling Class II AGA Gas Inc
Oct 29, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... Presence of Particulate Matter Class II Amerisource Health Services
Sep 25, 2015 FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane 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.