Browse Drug Recalls

615 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 615 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 615 FDA drug recalls in OH.

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DateProductReasonClassFirm
May 1, 2026 Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Con... Presence of a Foreign Substance; black particles observed in liquid Class II Safecor Health, LLC
May 1, 2026 Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
May 1, 2026 Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
Apr 30, 2026 Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are ... Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg ... Class II Safecor Health, LLC
Apr 16, 2026 Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, Fo... Labeling: Missing Label Class III American Regent, Inc.
Apr 9, 2026 Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit d... Failed Capsule Specifications: Out of specification results obtained during routine stability tes... Class II The Harvard Drug Group LLC
Apr 7, 2026 Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Sing... This recall is being conducted due to out of specification assay results in a limited number of b... Class II Hikma Pharmaceuticals USA INC
Mar 24, 2026 Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x ... Failed Dissolution Specifications Class II The Harvard Drug Group LLC
Mar 16, 2026 Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60... Failed tablet specifications. Class II Amerisource Health Services LLC
Feb 17, 2026 Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs)... Defective container; inadequately sealed blister packaging. Class II The Harvard Drug Group LLC
Feb 12, 2026 Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1... Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 ... Class III Slate Run Pharmaceuticals
Jan 14, 2026 Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) bliste... Defective container: Multiple customer complaints received for card seal defects observed on the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx on... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 10, 2025 Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx on... Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... Class II The Harvard Drug Group LLC
Oct 10, 2025 Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only,... Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... Class II The Harvard Drug Group LLC
Oct 9, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... Class II Amerisource Health Services LLC
Sep 22, 2025 Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Vo... Lack of assurance of sterility. Class II RC Outsourcing, LLC
Sep 15, 2025 Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x... Failed Dissolution Specifications. Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) bl... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack pe... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, R... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack pe... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 5, 2025 Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... Class II Cardinal Health Inc.
Jul 30, 2025 Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 29, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... Class II Amerisource Health Services LLC
Jul 11, 2025 Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... Class II Nostrum Laboratories, Inc.
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packag... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons,... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
May 15, 2025 Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blist... cGMP deviations Class II Amerisource Health Services LLC
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 9, 2025 Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens ... Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products... Class II Cardinal Health Inc.
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

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.