Reported Dec 17, 2025 · Ongoing
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 600 College Rd E Ste 4000 · Princeton, NJ · 08540-6636
Is this the product you have?
- Varenicline Tablets, 1mg, 56 Tablets, Rx only
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Lot codes and dates
- Lot # F2400244
- Exp Date10/31/2026
- Amount recalled
- 4800 54-count bottles
Where it was sold
- Nationwide
Why it was recalled
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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