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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
Northwind Ranitidine Tablets 150mg and 300mg Drugs NDMA (Nitrosodimethylamine) impurity Denton Pharma, Inc. dba Northwind Pharmaceuticals Terminated … announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. … to the manufacturer’s recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, which were repackaged … foods, including meats, dairy products and vegetables. The Ranitidine Tablets, USP, distributed by Northwind are …
PrecisionDose Ranitidine Oral Solution, USP 150 mg/10 mL Drugs Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Precision Dose Inc. Terminated … … Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being … reports of adverse events related to this recall to date. Ranitidine is a histamine-2 blocker, which decreases the …
AHP Ranitidine Liquid Unit Dose Cups Drugs NDMA (Nitrosodimethylamine) impurity American Health Packaging Terminated … Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose … vegetables. No reports of injury or adverse events to date. Ranitidine is used as a short-term treatment for active …
Sandoz Inc. Ranitidine Hydrochloride Capsules Drugs Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Sandoz Inc. Terminated … recalling all quantities and lots within expiryof Ranitidine Hydrochloride Capsules in the US to the consumer … above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not … and foods, including meats, dairy products, and vegetables. Ranitidine Hydrochloride Capsules is an oral product, …
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