United StatesVarenicline Tablets 1 mg, 56‑count prescription bottles (NDC 43598-908-56), lot F2400244, exp. 10/31/2026, distributed nationwide by Dr. Reddy’s Laboratories, are being recalled. A 9-month stability test showed the assay value for the affected lot was below the specification limit, indicating the drug is subpotent.
What's being recalled
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Recalling firm: Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States.
How to identify it
Lot # F2400244, Exp Date: 10/31/2026
The hazard
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distributed Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)