Varenicline Tartrate Tablet, Film Coated
FDA Recall NDC 43598-907
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Varenicline Tartrate (NDC 43598-907). A significant event, classified as Class III, was initiated on Nov 11, 2025 by Dr. Reddys Laboratories Inc.. The reported reason for this action was: "Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Nov 11, 2025
Dec 17, 2025
4800 54-count bottles
Recall Profile & Regulatory Data
Event ID
97957
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide
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
Batch or Lot Expiration Information
Lot# F2400244, Exp Date: 10/31/2026
Affected Packages Involved in this Recall
43598-907-56Product
43598-908-56Product
43598-023-53Product
43598-022-56Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
