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 | … the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in … the marketing of Quinapril tablets in September 2022. Nitrosamines are common in water and foods, including cured … and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of … | |
| Pfizer | Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg | Drugs | Due to N-Nitroso-Quinapril Content | Pfizer | Terminated | … the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. Nitrosamines are common in water and foods, including cured … and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of … | |
| CHANTIX | Varenicline tablets | Drugs | N-nitroso-varenicline above acceptable daily intake level | Pfizer | … the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA … outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured … | ||
| CHANTIX | Smoking cessation treatment | Drugs | N-Nitroso Varenicline content above ADI level | Pfizer | … the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer … outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured … |