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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
Alvogen Fentanyl Transdermal System 25 mcg/h transdermal patches Drugs There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch Alvogen, Inc. … NJ Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to … five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is: Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date …
Leiters, Compounding Health Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Drugs Potential for superpotent drug Leiters Health … batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for … twice. Item # Product Description Lot # Expiration F3355 FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium …
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