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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.