Class IIIReported 2025-12-17
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Recalled by Dr. Reddy's Laboratories, Inc.
Reason for Recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
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Recall NumberD-0219-2026ClassificationClass IIIStatusOngoingCategorydrugInitiated2025-11-11Reported2025-12-17DistributionDistributed NationwideCode InfoLot # F2400244, Exp Date: 10/31/2026Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.