Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in
Recalled December 17, 2025 · FDA recall D-0219-2026 · Dr. Reddy's Laboratories
Hazard
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. · FDA Class III
Units
4800 54-count bottles
Sold at
Distributed Nationwide
Description
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Product
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →