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Class III · Lower riskActive recall

Varenicline Tartrate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # F2400244, Exp Date: 10/31/2026
Where it was soldDistributed Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameVARENICLINE TARTRATE
Generic nameVARENICLINE TARTRATE
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC43598-908-56
Show the full FDA record
Full product labelVarenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionDistributed Nationwide
Quantity4800 54-count bottles
Recall initiated2025-11-11
Report date2025-12-17
Recall completed—
Recall numberD-0219-2026
ClassificationClass III
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.