Dr. Reddy's Laboratories, Inc.
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Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Lot # F2400244, Exp Date: 10/31/2026
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →