FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
Thyroid Tablets
Class ISuperpotent Drug
VITRUVIAS THERAPEUTICS INC · Aug 21, 2026
0.9% Sodium Chloride Injection
Class IPresence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
B BRAUN MEDICAL INC · Aug 19, 2026
Dextrose Injection
Class IPresence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Baxter Healthcare Corporation · Aug 17, 2026
0.9% Sodium Chloride Injection USP 500 mL
Class IPresence of particulate matter: Particulates identified as fiberglass
Baxter Healthcare Corporation · Aug 17, 2026
Lactated Ringer's Injection USP
Class IPresence of Particulate matter.
B BRAUN MEDICAL INC · Aug 12, 2026
Epinephrine Injection
Class IPresence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
American Regent, Inc. · Aug 11, 2026
Tyenne (tocilizumab-aazg) Injection
Class IPresence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Fresenius Kabi USA, LLC · Aug 10, 2026
Glutathione 200 mg/mL
Class IMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
OPTIMAL BALANCE PHARMACY · Aug 5, 2026
Morphine Sulfate Injection
Class ILabeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Fresenius Kabi USA, LLC · Aug 4, 2026
Optiray Imaging Bulk Package-350
Class IPresence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Liebel-Flarsheim Company LLC · Jul 31, 2026
Cefazolin in Dextrose
Class IPresence of Particulate Matter
Baxter Healthcare Corporation · Jul 24, 2026
Papaverine HCl Injection
Class IPresence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Cyclophosphamide for Injection
Class IPresence of Particulate Matter; identified as stainless steel
Sunny Pharmtech Inc. · Jul 17, 2026
Cyclophosphamide for Injection
Class IPresence of Particulate Matter; identified as stainless steel
Sunny Pharmtech Inc. · Jul 17, 2026
Glutathione (MDV)
Class IMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Victory Medical Center Pharmacy · Jul 1, 2026
Cetirizine Hydrochloride Tablets USP 5 mg
Class ICross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
JB Chemicals and Pharmaceuticals Ltd · Jun 24, 2026
Gas-X Extra Strength
Class IChemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Haleon US Holdings LLC · Jun 4, 2026
BEEKEEPER'S NATURALS Saline Nasal Spray
Class IMicrobial Contamination of Non-Sterile Products
BEEKEEPER'S NATURALS USA INC. · Jun 1, 2026
BD ChloraPrep FREPP Clear
Class INon-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CareFusion 213, LLC · May 28, 2026
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
Class INon-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC · May 28, 2026
DOXOrubin Hydrochloride Liposome injection
Class IPresence of Particulate matter: Particulate matter identified as glass.
SUN PHARMACEUTICAL INDUSTRIES INC · May 12, 2026
Lactated Ringer's Injection USP
Class IPresence of Particulate Matter.
B BRAUN MEDICAL INC · Apr 28, 2026
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%)
Class IMicrobial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Wisconsin Pharmacal Company · Apr 24, 2026
Revitaderm Wound Care Gel
Class IMicrobial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Blaine Labs Inc · Apr 8, 2026
Kian Pee Wan Capsules
Class IMarketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Buy-Herbal · Mar 21, 2026
Magnesium Sulfate in Water for Injection
Class IProduct mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Amneal Pharmaceuticals, LLC · Mar 18, 2026
Webcol Alcohol Prep pad (70% isopropyl 2 ply
Class INon-Sterility: microbial contamination identified as Paenibacillus phoenicis
Cardinal Health 200, LLC · Mar 2, 2026
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled…
Class ITemperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
McKesson · Jan 16, 2026
Rheumacare capsules
Class ICGMP Deviations: product found to contain lead.
HANDELNINE GLOBAL LLC · Dec 22, 2025
MR. 7 SUPER 700000 capsules
Class IMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
StuffbyNainax · Dec 15, 2025
ReBoost Nasal Spray
Class IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Medinatura New Mexico, inc. · Dec 12, 2025
ClearLife Allergy Nasal Spray
Class IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Medinatura New Mexico, inc. · Dec 12, 2025
Famotidine Injection
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Fresenius Kabi USA, LLC · Nov 6, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Otsuka ICU Medical LLC · Oct 29, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Otsuka ICU Medical LLC · Oct 29, 2025
SILINTAN 25/pills
Class IMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
ANTHONY TRINH, 123Herbals LLC · Oct 20, 2025
Mojo Max Fusion XXX
Class IMarketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Mohamed Hagar · Oct 8, 2025
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Class ISubpotent Drug: Testing revealed there was no oxytocin in the IV bag.
IntegraDose Compounding Services LLC · Sep 16, 2025
Green Lumber Natural Fuel For Men capsule
Class IMarketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Green Lumber Holdings, LLC · Aug 28, 2025
Cyclobenzaprine Hydrochloride Tablets
Class ILabeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Unichem Pharmaceuticals USA Inc. · Aug 27, 2025
Showing 40 of 143 Class I recalls (1,895 tracked in total).
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.