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
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
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
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 alcohol) 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 Syringe,…
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
Lactated Ringers's Injection USP
Class IPresence of Particulate Matter
B BRAUN MEDICAL INC · Aug 18, 2025
0.9% Sodium Chloride Injection USP
Class IPresence of Particulate Matter.
B BRAUN MEDICAL INC · Aug 18, 2025
NAD+ (Nicotinamide adenine dinucleotide) for Injection
Class IMicrobial Contamination of Sterile Products: elevated endotoxin levels
GenoGenix LLC · Jul 30, 2025
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ…
Class IMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
DermaRite Industries, LLC · Jul 17, 2025
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2…
Class IMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
DermaRite Industries, LLC · Jul 17, 2025
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle,…
Class IMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
DermaRite Industries, LLC · Jul 17, 2025
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per…
Class IMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
DermaRite Industries, LLC · Jul 17, 2025
Buffered Penicillin G Potassium for Injection
Class ILabeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Sandoz Inc · Jun 27, 2025
Cefazolin for Injection
Class ILabeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Sandoz Inc · Jun 27, 2025
ZICAM NASAL ALLCLEAR
Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Church & Dwight Inc · Jun 6, 2025
ZICAM COLD REMEDY MEDICATED NASAL SWABS
Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Church & Dwight Inc · Jun 6, 2025
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.…
Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Church & Dwight Inc · Jun 6, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Amneal Pharmaceuticals, LLC · Jun 2, 2025
UMOVY ACIDO HIALURONICO
Class IMarketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Umary-USA.com · May 21, 2025
Showing 40 of 129 Class I recalls (1,769 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.