⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

DrugsSource: FDA (drug) · Date: 2025-12-17

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Dr. Reddy's Laboratories, Inc.
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 / hazard
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Classification
Class III
Status
Ongoing
Distribution / sold at
Distributed Nationwide
Recall initiated
2025-11-11
Code info
Lot # F2400244, Exp Date: 10/31/2026
Product quantity
4800 54-count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Princeton
State
NJ
Country
United States
Event id
97957
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