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 |
|---|---|---|---|---|---|---|---|
| Lupin | Quinapril 20 and 40 mg tablets | Drugs | Presence of nitrosamine impurity, N-Nitroso-Quinapril | Lupin Pharmaceuticals Inc. | Terminated | … Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable … relate to this issue. Lupin discontinued the marketing of Quinapril tablets in September 2022. Nitrosamines are common … | |
| Pfizer | Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg | Drugs | Due to N-Nitroso-Quinapril Content | Pfizer | Terminated | … Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient … level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable … available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased … |