Varenicline Tablets, 1mg, 56 Tablets, Rx only
Recalled by Dr. Reddy's Laboratories, Inc.
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Dr. Reddy's Laboratories, Inc. has recalled Varenicline Tablets, 1mg, 56 Tablets, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 17, 2025 and was initiated on November 11, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Varenicline Tablets, 1mg, 56 Tablets, Rx only, with approximately 4800 54-count bottles affected. The company behind the recall is Dr. Reddy's Laboratories, Inc., based in Princeton, NJ. The FDA describes the product as: “Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56”
Why was Varenicline Tablets, 1mg, 56 Tablets, Rx only recalled?
According to the FDA, the stated reason for the recall is: “Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.”
What should you do?
If you think you may have bought Varenicline Tablets, 1mg, 56 Tablets, Rx only, compare it against the product description and identifying codes (Lot # F2400244, Exp Date: 10/31/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Dr. Reddy's Laboratories, Inc. or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- December 17, 2025
- Recall started
- November 11, 2025
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Varenicline Tablets, 1mg, 56 Tablets, Rx only recalled?+
According to the FDA: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo…
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Varenicline Tablets, 1mg, 56 Tablets, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0219-2026. Information last synced from the FDA on July 6, 2026.