Information
Dr. Reddy's Laboratories Recalls Varenicline Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0219-2026Drug / Pharmaceutical
Dr. Reddy's Laboratories Recalls Varenicline Tablets
Dr. Reddy's Laboratories, Inc. · Class III — Regulatory
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.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Distributed Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Dr. Reddy's Laboratories, Inc. on November 11, 2025. Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. This recall covers 4800 54-count bottles, distributed in Distributed Nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.