FDARecalled Dec 17, 2025 · #D-0219-2026
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Hazard
Class III — low health risk
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Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. Classification: Class III Distribution: Distributed Nationwide
Product 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
- Type
- Drugs
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Model numbers
- F2400244
- UPCs
- —