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FDANovember 11, 2025drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

dr reddy s laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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