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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
BD Alaris BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets Medical Devices Pump performance variations compared to the performance described in the user manual could impact infusion delivery BD … expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 … delivery in the following ways: Flow rate and loading bolus dose accuracy (over/under infusion), Upstream and downstream … care by developing innovative technology, services and solutions that help advance both clinical therapy for …
Mylan Institutional LLC Octreotide Acetate Injection, 500 mcg/mL Drugs Due to glass particulates Mylan Institutional LLC, a Viatris company Terminated … Octreotide Acetate Injection 500 mcg/mL 10 X 1 mL Single dose unit-of-use Syringe AJ21002 March 2024 Risk Statement: … advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect …
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