VARENICLINE TARTRATE
Recalling Firm / Manufacturer: Dr. Reddy's Laboratories, Inc.
(Princeton, NJ, United States)
FDA Recall Number: D-0219-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
VARENICLINE TARTRATE
Generic Name
VARENICLINE TARTRATE
Active Substance(s)
Not provided by source
Administration Route
Oral
National Drug Code (NDC)
43598-022
Total Quantity Recalled
4800 54-count bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Full Product Description
Packaging specifications and labeling details
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
December 17, 2025
Firm Initiation Date
November 11, 2025
FDA Classification Date
Dec 05, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # F2400244, Exp Date: 10/31/2026
Distribution Information
Geographic scope of affected shipments
Distributed Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0219-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC