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.
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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
11/01/2023	Rugby	OTC Ophthalmic Sterile Drops	Insanitary manufacturing conditions	The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
11/01/2023	LEADER	OTC Ophthalmic Sterile Drops	Insanitary manufacturing conditions	Cardinal Health, Inc.
10/25/2023	Exela and Civica Brands	Sodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection ELCYS (cysteine hydrochloride Injection), USP	Potential presence of particulate matter	Exela Pharma Sciences, LLC
10/23/2023	Multiple brands	Dietary Supplements with undeclared Diclofenac	Undeclared drug, Diclofenac	Botanical-Be
10/10/2023	Multiple brands	Over-the-Counter Drug and Medical Device products	Products were stored outside of labeled temperature requirements	Family Dollar
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

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