November 2025 FDA Recall Varenicline Tartrate by Dr. Reddy's Laboratories, Inc.
D-0219-2026 - Sub potent drug
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on November 11, 2025 for the product Varenicline Tartrate. The FDA reported the reason for recall as sub potent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0219-2026
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
11-11-2025
12-17-2025
4800 54-count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# F2400244, Exp Date: 10/31/2026
