FDAHealthNovember 11, 2025
Dr. Reddy's Laboratories, Inc. — Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
⚠️ Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 11, 2025
Distributed Nationwide
What's affected?
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Brand
- VARENICLINE TARTRATE
- Lot code
- F2400244
Additional details
Lot # F2400244, Exp Date: 10/31/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 4800 54-count bottles.
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