Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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Date	Product	Reason	Class	Firm
Sep 21, 2022	Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Ako...	Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo...	Class II	Akorn, Inc.
Sep 21, 2022	Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ...	Presence of Particulate Matter: A complaint was received for the presence of a single strand of h...	Class II	Viatris Inc
Sep 20, 2022	oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injec...	Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride ...	Class III	QuVa Pharma, Inc.
Sep 19, 2022	Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu...	Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 ...	Class III	UNICHEM PHARMACEUTICALS USA INC
Sep 16, 2022	Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT L...	Failed Viscosity specification: Slightly higher OOS results obtained for viscosity	Class III	ALMIRALL, LLC
Sep 16, 2022	Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx...	CGMP deviations: Out of specification results obtained during routine stability testing for ethan...	Class II	Novartis Pharmaceuticals Corporation
Sep 15, 2022	Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 ...	Lack of Assurance of Sterility	Class II	CIPLA
Sep 15, 2022	Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, ...	Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.	Class II	RemedyRepack Inc.
Sep 14, 2022	Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ...	Failed Stability Specifications: Out of specification results reported at 12-month stability test...	Class III	Dr. Reddy's Laboratories, Inc.
Sep 14, 2022	Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottl...	GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification...	Class II	Salon Technologies International Inc
Sep 14, 2022	Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) ...	Chemical Contamination: product found to contain benzene	Class I	Salon Technologies International Inc
Sep 13, 2022	Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for:...	Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.	Class II	Lupin Pharmaceuticals Inc.
Sep 12, 2022	Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distrib...	CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef...	Class II	Direct Rx
Sep 9, 2022	Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: ...	Marketed Without An Approved NDA/ANDA; Unapproved new drug	Class II	Justified Laboratories
Sep 9, 2022	Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: ...	Marketed Without An Approved NDA/ANDA; Unapproved new drug	Class II	Justified Laboratories
Sep 1, 2022	Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can...	CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All I...	Class II	SUPERIOR GLOVE WORKS, LTD.
Aug 31, 2022	Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) t...	cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop...	Class II	Akorn, Inc.
Aug 31, 2022	Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact...	cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop...	Class II	Akorn, Inc.
Aug 30, 2022	Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon S...	Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.	Class III	Woodbine Products Co Inc
Aug 29, 2022	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually...	Class II	Teva Pharmaceuticals USA Inc
Aug 26, 2022	QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusio...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC,...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Car...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 B...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, R...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Car...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, ...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion L...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infu...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, ...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infu...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 26, 2022	MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Caro...	Lack of Assurance of Sterility	Class II	Carolina Infusion
Aug 23, 2022	ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LE...	Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules	Class III	Leading Pharma, LLC
Aug 23, 2022	Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute...	CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing...	Class II	Teva Pharmaceuticals USA Inc
Aug 22, 2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ...	Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ...	Class II	CIPLA
Aug 22, 2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ...	Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ...	Class II	CIPLA
Aug 22, 2022	PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass...	Presence of particulate matter	Class I	Pfizer Inc.
Aug 17, 2022	Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By ...	CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef...	Class II	Padagis US LLC
Aug 15, 2022	Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99...	Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone...	Class II	Ultra Chem Labs Corp
Aug 15, 2022	Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99...	Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone...	Class II	Ultra Chem Labs Corp
Aug 10, 2022	Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Per...	cGMP deviation: Product held outside of appropriate temperature storage conditions.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm...	CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.	Class II	Nephron Sterile Compounding Center 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.