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
UNAVY ACIDO HIALURONICO
Class IMarketed 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 IMarketed 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 IPresence of Particulate Matter
Amneal Pharmaceuticals, LLC · Apr 17, 2025
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distribu…
Class IMarketed 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 IMarketed 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 IMarketed 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 IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
ELECTRO BUZZ
Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
SAINI TRADE INC · Apr 14, 2025
Levetiracetam 0.75% in Sodium Chloride Injection 1
Class ILABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Dr. Reddy's Laboratories, Inc. · Mar 13, 2025
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu…
Class IMarketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
One Source Nutrition, Inc, · Feb 20, 2025
PHENYLephrine added to 0.9% sodium chloride
Class IPresence of Particulate Matter
Central Admixture Pharmacy Services, Inc. · Feb 20, 2025
BD ChloraPrep Clear 1mL Applicators
Class INon-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
CareFusion 213, LLC · Feb 14, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
ICU Medical, Inc. · Feb 13, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
ICU Medical, Inc. · Feb 13, 2025
Fentanyl Transdermal System CII
Class IDefective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Alvogen, Inc · Jan 31, 2025
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch…
Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc. · Jan 28, 2025
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg a…
Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc. · Jan 28, 2025
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 70…
Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc. · Jan 28, 2025
Phenylephrine HCl Injection
Class IPresence of Particulate Matter.
Provepharm Inc. · Jan 21, 2025
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg
Class IFailed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Prograf (tacrolimus) capsules
Class IFailed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Adrenalin Chloride Solution (Epinephrine Nasal Solution
Class ILabeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
ENDO USA, Inc. · Dec 20, 2024
Systane Lubricant Eye Drops
Class INon-Sterility
Alcon Research LLC · Dec 18, 2024
FOUZEE SugarLin HERBAL FORMULA capsules
Class IMarketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
SHOPPERS- PLAZA · Dec 16, 2024
FORCE FOREVER 400mg Tablets
Class IMarketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
GNMart LLC · Dec 12, 2024
Nhan Sam Tuyet Lien Truy Phong Hoan
Class IMarketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Buy-Herbal · Dec 12, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
Clonazepam Orally Disintegrating Tablet
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
ZoomMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
PeakMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
VitalityXtra Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
ZapMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
Ascorbic Acid Inj. Solution
Class IPresence of Particulate Matter: Presence of glass particulates.
Staska Pharmaceuticals, Inc. · Sep 30, 2024
Veklury (remdesivir) for injection
Class IPresence of Particulate Matter: Presence of glass particle.
Gilead Sciences, Inc. · Sep 19, 2024
Vail-Bon Jie Yang Wan capsules
Class IMarketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
123Herbals · Sep 18, 2024
Atovaquone Oral Suspension
Class IMicrobial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Bionpharma Inc. · Sep 17, 2024
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Baxter Healthcare Corporation · Aug 1, 2024
0.9% Sodium Chloride Injection USP
Class IPresence of Particulate Matter
B. Braun Medical Inc · Jul 24, 2024
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.