Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets
- Recalling company
- Dr. Reddy's Laboratories, Inc.
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Reason
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Nov 11, 2025
- Reported
- Dec 17, 2025
- Distribution
- Distributed Nationwide
- Status
- Ongoing
- Quantity
- 4800 54-count bottles
- Lot / codes
- Lot # F2400244, Exp Date: 10/31/2026
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0219-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0219-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.