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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Varenicline tablets are used as a prescription medication to help adults quit smoking by reducing withdrawal symptoms and cravings. Consumers typically buy this product as part of a smoking cessation plan.
The recall is due to the drug being sub potent, meaning it might not deliver the intended effects in helping users quit smoking. This can lead to an ineffective treatment experience for those relying on the medication.
This recall is not part of a broader industry pattern.
Consumers may face health risks if they continue using the recalled Varenicline tablets. The urgency to discontinue use is high, as ineffective treatment could hinder smoking cessation efforts.
The lot number and expiration date can usually be found on the label of the bottle or packaging.
Expect a refund processing timeline of approximately 4-6 weeks after your request is submitted.
Document all correspondence with the manufacturer, including emails and phone calls. Keep receipts and photos of the product as proof of purchase.
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.
Not sure what to do next? Our guide walks you through the process step by step.
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