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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Sertraline Hydrochloride Tablets are prescribed to treat depression, anxiety, and other mood disorders. Patients typically use this medication daily as part of their treatment regimen.
The seal on the bottles may not adhere properly, risking exposure to contaminants that could compromise the integrity of the medication.
This recall is not part of a broader industry pattern.
Consumers who rely on Sertraline for mental health treatment face potential safety risks. The recall may cause inconvenience and necessitate obtaining replacements.
The lot number and expiration date can usually be found on the bottom or side of the bottle.
Expect processing for refunds or replacements to take 4 to 6 weeks.
Keep receipts, correspondence regarding the recall, and photographs of the affected product.
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.
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