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
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
Sep 25, 2015 FUROSEMIDE Tablets USP, 20 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
Jul 24, 2015 COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 m... Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short tr... Class II Boehringer Ingelheim Roxane Inc
Jun 26, 2015 Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3... Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class III American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11);... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-1... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-4... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Apr 2, 2015 Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe... Class II Boehringer Ingelheim Roxane Inc
Mar 2, 2015 Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx O... Failed dissolution specifications Class II American Health Packaging
Jan 6, 2015 Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and D... Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet caps... Class II American Health Packaging
Nov 19, 2014 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
Oct 10, 2014 MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... Subpotent; 6 month stability time point Class III American Health Packaging
Jul 31, 2014 CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx o... Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container clo... 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.