Browse Drug Recalls

1,749 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,749 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 1,749 FDA drug recalls, Class I.

Clear
DateProductReasonClassFirm
Jun 6, 2025 Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET... Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. Class I Church & Dwight Inc
Jun 2, 2025 Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100... Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial... Class I Amneal Pharmaceuticals, LLC
May 21, 2025 UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: ERE... Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclar... Class I Umary-USA.com
May 21, 2025 UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: ERE... Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclar... Class I Umary-USA.com
May 6, 2025 ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA... Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and... Class I EnShiShiXiangNiShangMaoYouXianGongSi
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 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 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
Mar 13, 2025 Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... Class I Dr. Reddy's Laboratories, Inc.
Feb 20, 2025 Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Ca... Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and... Class I One Source Nutrition, Inc,
Feb 20, 2025 PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx O... Presence of Particulate Matter Class I Central Admixture Pharmacy Services, Inc.
Feb 14, 2025 BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Class I CareFusion 213, LLC
Feb 13, 2025 POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case,... Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain ... Class I ICU Medical, Inc.
Feb 13, 2025 POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container... Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may... Class I ICU Medical, Inc.
Jan 31, 2025 Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packag... Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a... Class I Alvogen, Inc
Jan 28, 2025 SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 28, 2025 SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 m... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 28, 2025 SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 21, 2025 Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Phar... Presence of Particulate Matter. Class I Provepharm Inc.
Dec 23, 2024 Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, ... Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Astellas Pharma US Inc.
Dec 23, 2024 Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Produc... Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Astellas Pharma US Inc.
Dec 20, 2024 Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... Class I ENDO USA, Inc.
Dec 18, 2024 Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... Non-Sterility Class I Alcon Research LLC
Dec 16, 2024 FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Di... Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with und... Class I SHOPPERS- PLAZA
Dec 12, 2024 FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO AL... Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofen... Class I GNMart LLC
Dec 12, 2024 Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured... Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undecla... Class I Buy-Herbal
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 4, 2024 ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomM... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Nov 4, 2024 PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distribut... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Nov 4, 2024 VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Dist... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Nov 4, 2024 ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Sep 30, 2024 Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, ... Presence of Particulate Matter: Presence of glass particulates. Class I Staska Pharmaceuticals, Inc.
Sep 19, 2024 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: Presence of glass particle. Class I Gilead Sciences, Inc.
Sep 18, 2024 Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sd... Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone ... Class I 123Herbals
Sep 17, 2024 Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distribu... Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with C... Class I Bionpharma Inc.
Aug 1, 2024 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Baxter Healthcare Corporation
Jul 24, 2024 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... Presence of Particulate Matter Class I B. Braun Medical Inc
Jul 18, 2024 Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Dicl... Class I MAIN PRODUCTS INC
Jul 12, 2024 Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and ... Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared ... Class I Supercore Products Group Inc.
Jul 12, 2024 Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared D... Class I SoloVital
Jul 12, 2024 Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199 Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared ... Class I Supercore Products Group Inc.
Jul 11, 2024 Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 ... Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the ... Class I Aurobindo Pharma USA Inc
Jul 10, 2024 Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... Class I Endo Pharmaceuticals, Inc.
Jul 8, 2024 Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... Class I Hikma Pharmaceuticals USA 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.