Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Varenicline Tablets Recalled by Dr. Reddy's Laboratories, Inc. Due to Sub potent drug: during the 9-month stability test...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dr. Reddy's Laboratories, Inc. directly.
Affected Products
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Quantity: 4800 54-count bottles
Why Was This Recalled?
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report