Why it was recalled
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
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
Lot numbers, UPCs & expiration codes
Lot # F2400244, Exp Date: 10/31/2026
Where it was sold
Distributed Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0219-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 11, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- 4800 54-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0219-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97957
- Address
- 600 College Rd E Ste 4000
- Code information
- Lot # F2400244, Exp Date: 10/31/2026
- Postal code
- 08540-6636
- Report date
- Dec 17, 2025
- Product type
- Drugs
- Recall number
- D-0219-2026
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4800 54-count bottles
- Reason for recall
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide
- Recall initiation date
- Nov 11, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2025