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Recalls, Market Withdrawals, & Safety Alerts

 

The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.

The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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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 Product Type Recall Reason Description Company Name Terminated Recall Excerpt
BionPharma Atovaquone Oral Suspension, 750 mg/mL Drugs Product found to be contaminated with Cohnella bacteria Bionpharma Inc. … Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer … is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life … Lot No. Expiration Date October 26, 2023 December 05, 2023 Atovaquone Oral Suspension 69452-252-87 2310083 September …
AVpak Atovaquone Oral Suspension, USP 750mg/5mL Drugs Potential Bacillus cereus contamination AvKARE, LLC … –AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the … is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life … any reports of adverse events related to this recall. Atovaquone Oral Suspension, USP is indicated for prevention …
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