Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 17, 2025 | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), M... | Presence of Particulate Matter | Class I | Amneal Pharmaceuticals, LLC |
| 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 | HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette,... | Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was ... | Class III | OurPharma 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 | Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distr... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| 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 | MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distr... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: He... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Dist... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| 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. |
| Apr 10, 2025 | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Ma... | Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... | Class II | Lupin Pharmaceuticals Inc. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, M... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Singl... | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Class II | Eugia US LLC |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, ... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 9, 2025 | Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes,... | CGMP Deviations | Class II | Apipharma |
| 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 9, 2025 | Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g... | CGMP Deviations | Class II | Apipharma |
| Apr 3, 2025 | chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles... | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... | Class II | Zydus Pharmaceuticals (USA) 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 |
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.