FDAClass IIDecember 17, 2025

Sertraline Hydrochloride Tablets USP recall

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC…

Why was Sertraline Hydrochloride Tablets USP recalled?

Defective container - seal not adhering to bottles

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # QB00865, exp. date Feb 2028

Product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
52,128 bottles
Distribution
Nationwide.
Recall date
December 17, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls