Pfizer Inc.: Drug Recall
Recall #D-0809-2021 · 08/13/2021
Class II: Risk
Recall Details
- Recall Number
- D-0809-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Pfizer Inc.
- Status
- Ongoing
- Date Initiated
- 08/13/2021
- Location
- New York, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Product Description
Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.
Distribution Pattern
Nationwide
Other Recalls by Pfizer Inc.
- Class II: Risk 08/04/2025
- Class II: Risk 08/04/2025
- Class II: Risk 07/10/2025
- Class II: Risk 07/10/2025
- Class II: Risk 05/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.