FDA Drug · D-0219-2026

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Class III · Ongoing

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Affected lots / codes — check yours against thisLot # F2400244, Exp Date: 10/31/2026

Recalling firm: Dr. Reddy's Laboratories, Inc., Princeton, NJ
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: 4800 54-count bottles
Distribution: Distributed Nationwide
Recall initiated: November 11, 2025
Classified: December 5, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0219-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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