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.

Clear
DateProductReasonClassFirm
Apr 2, 2025 Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, M... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Apr 2, 2025 Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... Lack of assurance of sterility. Bacterial contamination detected in some media fill units Class II Amerisource Health Services LLC
Mar 24, 2025 Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 i... cGMP Deviations: Received notification from their supplier requesting they perform a recall due t... Class II Amerisource Health Services LLC
Mar 7, 2025 Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: ... CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Class II Slate Run Pharmaceuticals
Mar 7, 2025 Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: ... CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Class II Slate Run Pharmaceuticals
Feb 17, 2025 Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg ... Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... Class II Safecor Health, LLC
Feb 17, 2025 Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solut... Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... Class II Safecor Health, LLC
Feb 17, 2025 Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Suppl... Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... Class II Safecor Health, LLC
Feb 17, 2025 Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrat... Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... Class II Safecor Health, LLC
Feb 17, 2025 Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral S... Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... Class II Safecor Health, LLC
Jan 7, 2025 Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... Presence of Foreign Tablets/Capsules Class II Amerisource Health Services LLC
Dec 19, 2024 Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, ... Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configur... Class III West-Ward Columbus Inc
Dec 17, 2024 glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) ca... Failed Dissolution Specifications: Class II Amerisource Health Services LLC
Dec 13, 2024 Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... Presence of Foreign Tablets/Capsules Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Ma... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Ma... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Nov 14, 2024 Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class II Amerisource Health Services LLC
Nov 14, 2024 Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class II Amerisource Health Services LLC
Nov 14, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class II Amerisource Health Services LLC
Jun 25, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-... Failed Dissolution Specifications Class I Amerisource Health Services LLC
Jun 24, 2024 buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg,... Failed Dissolution Specifications; the product is dissolving faster than the specified limits. Class II Amerisource Health Services LLC
May 14, 2024 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL... Lack of Assurance of Sterility. Class II American Regent, Inc.
May 13, 2024 Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Mult... Subpotent product in addition to having out-of-specification results for impurities. Class II American Regent, Inc.
Feb 1, 2024 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... Class III Amerisource Health Services LLC
Jan 25, 2024 Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... CGMP Deviations Class II Amerisource Health Services LLC
Jan 11, 2024 Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... Failed Impurities/Degradation Specification. Class II Amerisource Health Services LLC
Dec 26, 2023 Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose c... Superpotent drug: Assay results were slightly above specification at the time zero point. Class III Amerisource Health Services LLC
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Sep 22, 2023 Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx onl... Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two ... Class III West-Ward Columbus Inc
Sep 1, 2023 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart... Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged prod... Class III Amerisource Health Services LLC
Jun 23, 2023 Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... Class II Amerisource Health Services LLC
Mar 17, 2023 Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 6800... CGMP Deviations: recalling drug products following an FDA inspection. Class II Amerisource Health Services LLC
Mar 17, 2023 Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 6... CGMP Deviations: recalling drug products following an FDA inspection. Class II Amerisource Health Services LLC
Mar 17, 2023 Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 680... CGMP Deviations: recalling drug products following an FDA inspection. Class II Amerisource Health Services LLC
Mar 16, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (1... Failed Dissolution Specifications: Out of specification dissolution results above specified values. Class II Amerisource Health Services LLC
Jan 27, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... Class II Amerisource Health Services LLC
Jan 11, 2023 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 10... Failed Dissolution Specifications: This recall is being initiated in support of the recall by the... Class II Amerisource Health Services LLC
Dec 27, 2022 BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton,... Failed Impurities/Degradation Specifications Class II Amerisource Health Services LLC
Dec 20, 2022 Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di... Failed Impurities/Degradations Specifications Class II Amerisource Health Services LLC
Aug 30, 2022 Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon S... Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. Class III Woodbine Products Co Inc
Jul 27, 2022 Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx O... Subpotent Drug Class III Amerisource Health Services LLC
Jul 8, 2022 Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.2... Labeling: Missing label: the product tube was missing a label and contained a different formulation. Class III The Procter & Gamble Company

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.