FDAFDA · Food and drugs·Recall number D-0219-2026
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Published December 17, 2025 · Recall initiated: November 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VARENICLINE TARTRATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Distributed Nationwide
- Lot
- Lot # F2400244, Exp Date: 10/31/2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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