← FDA ENFORCEMENT
D-0219-2026Class III

Dr. Reddy's Laboratories, Inc.

Recalling firm
Dr. Reddy's Laboratories, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-17
Distribution
Distributed Nationwide
Firm state
NJ
Product quantity
4800 54-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Code / lot info

Lot # F2400244, Exp Date: 10/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.