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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| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| Time-Cap Labs Inc. | Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg | Drugs | Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Marksans Pharma Limited | Terminated | … June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer … | |
| Riomet ER | Metformin Hydrochloride for Extended-Release Oral Suspension | Drugs | Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Sun Pharmaceutical Industries | Terminated | … Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the … |