Browse Drug Recalls

1,723 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,723 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 1,723 FDA drug recalls — Class I.

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DateProductReasonClassFirm
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.
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 21, 2024 Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... Class I A-S Medication Solutions LLC
Jun 5, 2024 STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms Class I Homeocare Laboratories, Inc.
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... Failed Dissolution Specifications Class I Glenmark Pharmaceuticals Inc., USA
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... Failed Dissolution Specifications Class I Glenmark Pharmaceuticals Inc., USA
May 28, 2024 Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose ... Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Class I Sagent Pharmaceuticals
May 28, 2024 Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Do... Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Class I Sagent Pharmaceuticals
May 24, 2024 suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broa... Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) Class I SYNCHRONICITY SPA INC, DBA SUNTE
Apr 29, 2024 Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Class I Hikma Injectables USA Inc
Apr 22, 2024 Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, dis... Marketed Without An Approved NDA/ANDA Class I Stop Clopez Corp
Apr 20, 2024 Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Class I Revive Rx LLC dba Revive Rx Pharmacy
Apr 8, 2024 Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 8, 2024 Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Class I AvKARE
Mar 23, 2024 Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 23, 2024 Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 21, 2024 Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... Superpotent Drug: Due to overfilling of drug powder Class I Amneal Pharmaceuticals of New York, LLC
Mar 19, 2024 GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres L... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving ... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Samurai-X Honey 6800, UPC 2 56891 27553 3. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale 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.