FDA recall D-0219-2026

Dr. Reddy's Laboratories, Inc. · Class III · drug

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.

Distribution

Distributed Nationwide

Key facts

Status
Ongoing
Initiation date
2025-11-11
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0219-2026