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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
Fresenius Kabi Tyenne Injection 400 mg/20 mL vial Drugs Due to Presence of Glass Particles Fresenius Kabi … Fresenius Kabi … Fresenius Kabi … August 10, 2026 – LAKE ZURICH, Ill.— … questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through …
Fresenius Kabi Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL Drugs Due to a label mix-up Fresenius Kabi … Fresenius Kabi … Fresenius Kabi … FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE … questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through …
Fresenius Kabi Famotidine Injection, USP 20 mg per 2 mL Drugs Out-of-specification endotoxin results Fresenius Kabi USA, LLC … Fresenius Kabi … Fresenius Kabi USA, LLC … [alerts type="info"] “Press has …
Envoachem Pharmaceuticals Dyural-40 and Dyural-80 Drugs Due to Latex Hazard Asclemed USA Inc dba Envoachem Pharmeceuticals … Envoachem Pharmaceuticals … Asclemed USA Inc dba Envoachem Pharmeceuticals … Torrance, CA, … include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling …
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