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.

All (1617)Class I (122)Class II (1336)Class III (158)

Gas-X Extra Strength
Class I
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Haleon US Holdings LLC · Jun 4, 2026
DOXOrubin Hydrochloride Liposome injection
Class I
Presence of Particulate matter: Particulate matter identified as glass.
SUN PHARMACEUTICAL INDUSTRIES INC · May 12, 2026
Lactated Ringer's Injection USP
Class I
Presence of Particulate Matter.
B BRAUN MEDICAL INC · Apr 28, 2026
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%)
Class I
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Wisconsin Pharmacal Company · Apr 24, 2026
Magnesium Sulfate in Water for Injection
Class I
Product 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 I
Non-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 I
Temperature 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 I
CGMP Deviations: product found to contain lead.
HANDELNINE GLOBAL LLC · Dec 22, 2025
MR. 7 SUPER 700000 capsules
Class I
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
StuffbyNainax · Dec 15, 2025
ReBoost Nasal Spray
Class I
Microbial 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 I
Microbial 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 I
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Fresenius Kabi USA, LLC · Nov 6, 2025
POTASSIUM CHLORIDE Inj.
Class I
Labeling: 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 I
Labeling: 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 I
Marketed 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 I
Marketed 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 I
Subpotent 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 I
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Green Lumber Holdings, LLC · Aug 28, 2025
Cyclobenzaprine Hydrochloride Tablets
Class I
Labeling: 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 I
Presence of Particulate Matter
B BRAUN MEDICAL INC · Aug 18, 2025
0.9% Sodium Chloride Injection USP
Class I
Presence of Particulate Matter.
B BRAUN MEDICAL INC · Aug 18, 2025
NAD+ (Nicotinamide adenine dinucleotide) for Injection
Class I
Microbial 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 I
Microbial 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 I
Microbial 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 I
Microbial 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 I
Microbial 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 I
Labeling: 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 I
Labeling: 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 I
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Church & Dwight Inc · Jun 6, 2025
ZICAM COLD REMEDY MEDICATED NASAL SWABS
Class I
Microbial 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 I
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Church & Dwight Inc · Jun 6, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class I
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Amneal Pharmaceuticals, LLC · Jun 2, 2025
UMOVY ACIDO HIALURONICO
Class I
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Umary-USA.com · May 21, 2025
UNAVY ACIDO HIALURONICO
Class I
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Umary-USA.com · May 21, 2025
ENDURANCE BOOST WITH HORNY GOAT WEED
Class I
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
EnShiShiXiangNiShangMaoYouXianGongSi · May 6, 2025
Ropivacaine Hydrochloride Injection
Class I
Presence of Particulate Matter
Amneal Pharmaceuticals, LLC · Apr 17, 2025
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distribu…
Class I
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distribu…
Class I
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
Male Ultra Pro
Class I
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distrib…
Class I
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025

Showing the 40 most recent Class I recalls of 1617 tracked.

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.

FDA drug recalls

Gas-X Extra Strength

DOXOrubin Hydrochloride Liposome injection

Lactated Ringer's Injection USP

MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%)

Magnesium Sulfate in Water for Injection

Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,…

Rheumacare capsules

MR. 7 SUPER 700000 capsules

ReBoost Nasal Spray

ClearLife Allergy Nasal Spray

Famotidine Injection

POTASSIUM CHLORIDE Inj.

POTASSIUM CHLORIDE Inj.

SILINTAN 25/pills

Mojo Max Fusion XXX

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use

Green Lumber Natural Fuel For Men capsule

Cyclobenzaprine Hydrochloride Tablets

Lactated Ringers's Injection USP

0.9% Sodium Chloride Injection USP

NAD+ (Nicotinamide adenine dinucleotide) for Injection

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ…

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2…

DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle,…

PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per…

Buffered Penicillin G Potassium for Injection

Cefazolin for Injection

ZICAM NASAL ALLCLEAR

ZICAM COLD REMEDY MEDICATED NASAL SWABS

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.…

Sulfamethoxazole and Trimethoprim Tablets

UMOVY ACIDO HIALURONICO

UNAVY ACIDO HIALURONICO

ENDURANCE BOOST WITH HORNY GOAT WEED

Ropivacaine Hydrochloride Injection

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distribu…

MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distribu…

Male Ultra Pro

ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distrib…

What the recall classes mean