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 for recall: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was  below specification limit.
Recall initiated: 20251111
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated