Browse Drug Recalls

14,136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,136 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 14,136 FDA drug recalls — Class II.

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DateProductReasonClassFirm
Apr 25, 2025 Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Sin... Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 25, 2025 Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) an... Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Fl... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulf... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - ... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesi... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%,... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%,... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulos... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Pro... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodiu... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromello... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 22, 2025 Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repack... CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. Class II RemedyRePack Inc.
Apr 21, 2025 PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, M... CGMP Deviations; potential temperature excursions due to transit delays Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 21, 2025 BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-10... CGMP Deviations; potential temperature excursions due to transit delays Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 21, 2025 Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 21, 2025 EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use O... CGMP Deviations; potential temperature excursions due to transit delays Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 21, 2025 Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-d... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 18, 2025 Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufacture... cGMP Deviations Class II Preferred Pharmaceuticals, 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 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 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Apr 15, 2025 Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed b... cGMP deviations Class II Pharmadel, LLC
Apr 15, 2025 FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0... Lack of Assurance of Sterility Class II Apollo Care, LLC
Apr 15, 2025 DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharm... cGMP deviations Class II Pharmadel, LLC
Apr 15, 2025 Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distribut... cGMP deviations Class II Pharmadel, LLC
Apr 15, 2025 Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (... cGMP deviations Class II Pharmadel, LLC
Apr 15, 2025 Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), ... Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are ... Class II Nubratori, Inc
Apr 15, 2025 DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl... cGMP deviations Class II Pharmadel, LLC
Apr 15, 2025 Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tab... cGMP deviations Class II Pharmadel, LLC
Apr 14, 2025 ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 ... CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Apr 14, 2025 Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Breckenridge Pharmaceutical, Inc
Apr 14, 2025 Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, ... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Breckenridge Pharmaceutical, Inc
Apr 10, 2025 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, ... Subpotent Class II ACCORD HEALTHCARE, INC.
Apr 10, 2025 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, M... Subpotent Class II ACCORD HEALTHCARE, 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.