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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
ICU Medical 20 mEq Potassium Chloride Injection Drugs Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection Otsuka ICU Medical LLC … recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label … Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. Otsuka …
ICU Medical POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq Drugs Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. ICU Medical … ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU …
Blue Point Laboratories Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count Drugs Failed dissolution American Health Packaging … Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, … dissolution. Risk Statement: The failed dissolution of potassium chloride extended-release capsules may cause high …
Glenmark Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count Drugs Failed dissolution Glenmark Pharmaceuticals, Inc. … No NDC Product Name Batch No. Expiry Date 1. 68462-357-01 Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K - 100 count 17221393 Jun-24 2. 68462-357-01 Potassium Chloride Extended-Release Capsules USP (750 mg) 10 …
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