Dr. Reddy's recalls varenicline 1mg tablets because they are weaker than intended
In a 9-month stability test, the affected lot tested below the allowed strength, which means the tablets contain less of the drug than they should.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Hazard
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Units
- 4800 54-count bottles
- Where sold
- Distributed Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- December 5, 2025
- Recall started
- November 11, 2025
- FDA enforcement report
- December 17, 2025
- Identifiers
- Codes: Lot # F2400244, Exp Date: 10/31/2026
- FDA recall number: D-0219-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Reason for recall
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Classification
- Class III (Ongoing)
- Distribution
- Distributed Nationwide
- Quantity
- 4800 54-count bottles
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