Class III

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

Dr. Reddy's Laboratories, Inc. · November 11, 2025

Reason for Recall

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

Distribution

Distributed Nationwide

States Affected

NATIONWIDE

Quantity Affected

4800 54-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0219-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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