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

The list below includes voluntary drug recalls in which public notification has been issued.

Visit FDA’s role in drug recalls for more information.
Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
Follow FDA Recall Information on X (formerly Twitter).

Search

Filter by

Terminated Recall - Any -YesNo

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	Terminated Recall	Excerpt
10/03/2023	KVK Tech	Betaxolol Tablets, USP	Potential Presence of Oxycodone HCl tablet	KVK-Tech, Inc.
10/02/2023	Hospira	4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP	Potential Presence of Glass Particulates	Hospira, Inc.
10/02/2023	Ion and Restore brands	Nasal Sprays	Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp.	Biomic Sciences
09/28/2023	Brexafemme	Antifungal oral medication	Potential cross contamination with non-antibacterial beta-lactam drug substance	Scynexis, Inc.
09/22/2023	VistaPharm	Sucralfate Oral Suspension 1g/10mL	Potential contamination with Bacillus cereus	Potential contamination with Bacillus cereus
09/11/2023	Novartis	Sandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mL	Crystal formation which could potentially result in incorrect dosing	Novartis Pharmaceuticals Corporation
09/08/2023	TheraBreath	TheraBreath Kids Strawberry Splash Oral Rinse	Device & Drug Safety/Microbial Contamination	Church & Dwight Co., Inc.
09/05/2023	WEFUN	Dietary Supplement with undeclared Sildenafil	Undeclared drug, Sildenafil	Hua Da Trading Inc dba Wefun Inc
08/31/2023	Marlex Pharmaceuticals, Inc.	Digoxin Tablets USP, 0.125mg and 0.25mg	Label Mix-Up	Marlex Pharmaceuticals, Inc.
08/26/2023	Dr. Berne’s	MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5% Solution	Bacterial and Fungal Contamination	Dr. Berne’s Whole Health Products

Download XLSX