Dr. Reddy's Laboratories recalled 4,800 bottles of Varenicline tablets on November 11, 2025, due to sub potent drug levels. The affected lot failed stability tests, posing potential health risks to users. Consumers should stop using the product immediately and consult healthcare providers.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Consumers and healthcare providers should stop using this product immediately. Contact Dr. Reddy's Laboratories, Inc. or your healthcare provider for guidance. Notification method: Letter
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The recall affects Varenicline Tablets, 1mg, 56 tablets per bottle, distributed nationwide. The affected lot number is F2400244, with an expiration date of October 31, 2026.
The recall involves a sub potent drug, which means the active ingredient may not be effective. The assay value for the affected lot fell below the specification limit during a 9-month stability test.
No reported incidents, injuries, or deaths related to this recall have been mentioned. Users are advised to stop use to avoid potential health risks.
Stop using Varenicline tablets immediately. Contact Dr. Reddy's Laboratories or your healthcare provider for further guidance and potential alternatives.
For more information, contact Dr. Reddy's Laboratories at their official website or customer service line. Additional details are available at the FDA recall page.
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