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

FDA recall notice · announced December 17, 2025 · Dr. Reddy's Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Distributed Nationwide
Lot/code information: Lot # F2400244, Exp Date: 10/31/2026
Quantity: 4800 54-count bottles
Status: Ongoing
Products in this recall event:
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 (D-0219-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.