Drug recalls
FDA drugs recall events posted in the Enforcement Report since Jan 1, 2025 that include a Class I product — FDA's most serious category. 63 events, newest first. Class II and III recalls and older records are in search.
Browse by reason
- Sterility concerns 18
- Microbial contamination 18
- Labeling errors 9
- Undeclared allergens 9
- Foreign material 6
Recalls
-
Par Health USA, LLC drug recall: Argatroban Injection
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
-
Greenwich Rx drug recall: Glutathione Injection
Microbial Contamination of Sterile Products
-
Vitruvias Therapeutics Inc drug recall: Thyroid Tablets
Superpotent Drug
-
B Braun Medical Inc drug recall: 0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
-
Baxter Healthcare Corporation drug recall: Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
-
American Regent, Inc. drug recall: Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and…
-
Baxter Healthcare Corporation drug recall: 0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
-
Optimal Balance Pharmacy drug recall: Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
-
B Braun Medical Inc drug recall: Lactated Ringer's Injection USP
Presence of Particulate matter.
-
Fresenius Kabi USA, LLC drug recall: Tyenne
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
-
Fresenius Kabi USA, LLC drug recall: Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
-
American Regent, Inc. drug recall: Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
-
Liebel-Flarsheim Company LLC drug recall: Optiray Imaging Bulk Package-350
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
-
Victory Medical Center Pharmacy drug recall: Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
-
Baxter Healthcare Corporation drug recall: Cefazolin in Dextrose
Presence of Particulate Matter
-
Buy-Herbal drug recall: Kian Pee Wan Capsules
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
-
Sunny Pharmtech Inc. drug recall: Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
-
JB Chemicals and Pharmaceuticals Ltd drug recall: Cetirizine Hydrochloride Tablets USP 5 mg
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg.…
-
Blaine Labs Inc drug recall: Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
-
CareFusion 213, LLC drug recall: BD ChloraPrep Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
-
Beekeeper's Naturals USA Inc. drug recall: BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
-
Haleon US Holdings LLC drug recall: Gas-X Extra Strength
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
-
Sun Pharmaceutical Industries Inc drug recall: DOXOrubin Hydrochloride Liposome injection
Presence of Particulate matter: Particulate matter identified as glass.
-
Wisconsin Pharmacal Company drug recall: MG217 Multi-Symptom Treatment Cream & Skin Protectant
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
-
B Braun Medical Inc drug recall: Lactated Ringer's Injection USP
Presence of Particulate Matter.
-
Amneal Pharmaceuticals, LLC drug recall: Magnesium Sulfate in Water for Injection
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.
-
Cardinal Health 200, LLC drug recall: Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
-
ANTHONY TRINH, 123Herbals LLC drug recall: SILINTAN 25/pills
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
-
StuffbyNainax drug recall: MR. 7 SUPER 700000 capsules
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
-
Mohamed Hagar drug recall: Mojo Max Fusion XXX
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
-
McKesson drug recall: Udenyca
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required…
-
Handelnine Global LLC drug recall: Rheumacare capsules
CGMP Deviations: product found to contain lead.
-
Green Lumber Holdings, LLC drug recall: Green Lumber Natural Fuel For Men capsule
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
-
Medinatura New Mexico, inc. drug recall: ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
-
Fresenius Kabi USA, LLC drug recall: Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
-
Otsuka ICU Medical LLC drug recall: POTASSIUM CHLORIDE Inj
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.…
-
IntegraDose Compounding Services LLC drug recall: Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
-
GenoGenix LLC drug recall: Alpha Lipoic Acid for Injection
Lack of Assurance of Sterility
-
Unichem Pharmaceuticals USA Inc. drug recall: Cyclobenzaprine Hydrochloride Tablets
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…
-
B Braun Medical Inc drug recall: Lactated Ringers's Injection USP
Presence of Particulate Matter
-
DermaRite Industries, LLC drug recall: DermaKleen
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
-
Sandoz Inc drug recall: Cefazolin for Injection
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.…
-
Church & Dwight Inc drug recall: Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
-
Umary-USA.com drug recall: Unavy Acido Hialuronico
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
-
Amneal Pharmaceuticals, LLC drug recall: Sulfamethoxazole and Trimethoprim Tablets
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
-
Saini Trade Inc drug recall: Male Ultra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
-
EnShiShiXiangNiShangMaoYouXianGongSi drug recall: Endurance Boost With Horny Goat Weed
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
-
Amneal Pharmaceuticals, LLC drug recall: Ropivacaine Hydrochloride Injection
Presence of Particulate Matter
-
Dr. Reddy's Laboratories, Inc. drug recall: Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: 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…
-
Ascent Consumer Products Inc. drug recall: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus