Drug Recalls

Jump to Recall Announcements

A drug recall is one of the most effective ways to protect consumers from a defective or potentially harmful medicine. A recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk.

More Information on Drug Recalls

Visit the Drug recall information for consumers, health care professionals and industry page for information on the drug recall process.
Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.

Stay up to date on FDA Recall Information by following us on X.

Drug Recall Announcements by Company

Filter by

Terminated Recall

A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date	Brand Name(s)	Product Description	Recall Reason Description	Company Name
09/21/2026	ICU Medical LLC	0.9% Sodium Chloride Injection, USP, 100 mL	Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection	Otsuka ICU Medical LLC
09/21/2026	Par Pharmaceutical	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion	Presence of particulate matter identified as cellulose or stopper material	Par Health
09/21/2026	Niwali	Tejocote Capsules and Pieces	Products contain yellow oleander (Thevetia peruviana).	Global Mix Inc.
09/13/2026	Centric Compounding	Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune Boost 30 mL multidose vial	Elevated Endotoxin level	Centric Compounding LLC
09/03/2026	B. Braun	0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container	Presence of particulate matter identified as iron oxide	B. Braun Medical Inc.
09/03/2026	American Regent, Inc.	Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial	Presence of particulate matter and lack of sterility assurance	American Regent, Inc.
08/31/2026	Lipofit	Lipofit Extreme 2.0 Fat Burner Dietary Supplement	Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)	Ana Salazar Modela Tu Cuerpo Inc.
08/26/2026	Baxter	0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container	Potential presence of particulate matter identified as fiberglass in the solution.	Baxter International Inc.
08/25/2026	Baxter	Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container	Potential presence of particulate matter identified as fiberglass in the solution	Baxter International Inc.
08/25/2026	Baxter	70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container	Potential presence of particulate matter identified as stainless steel particles in the solution.	Baxter International Inc.

Download XLSX