Lupin Pharmaceuticals recalled 52,128 bottles of Sertraline Hydrochloride Tablets on November 5, 2025. Consumers reported issues with defective seals that do not adhere to the bottles. The recall follows a Class II classification due to potential contamination risks.
Defective container - seal not adhering to bottles
Consumers and healthcare providers should stop using this product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: Letter
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The recall involves Sertraline Hydrochloride Tablets USP, 100 mg, in 90-tablet bottles. Lot number QB00865 with an expiration date of February 2028 is affected. The product was distributed nationwide.
The defective container seal may lead to contamination of the tablets. This poses a high hazard risk as it could compromise medication safety.
There have been no reported injuries or adverse incidents directly linked to this defect. However, the risk of contamination remains a concern.
Stop using the product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance regarding the recall.
For more details, visit the FDA's recall page or contact Lupin Pharmaceuticals directly at their customer service number.
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