Class III
Ongoing
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
This recall is currently active, issued December 17, 2025. It was issued by Dr. Reddy'S Laboratories, Inc..
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- November 11, 2025
- Posted
- December 17, 2025
- Recall Number
- D-0219-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4800 54-count bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Distribution
Distributed Nationwide
Lot / Code Info
Lot # F2400244, Exp Date: 10/31/2026
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