Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Prince...
FDA Recall #D-0219-2026 — Class III — November 11, 2025
Product Description
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.
Recalling Firm
Dr. Reddy's Laboratories, Inc. — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4800 54-count bottles
Distribution
Distributed Nationwide
Code Information
Lot # F2400244, Exp Date: 10/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated