Recall
FDAHealthNovember 5, 2025

Lupin Pharmaceuticals Inc. — Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

⚠️ Defective container - seal not adhering to bottles

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
November 5, 2025

Nationwide.

What's affected?

Product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lot code
QB00865

Additional details

Lot # QB00865, exp. date Feb 2028

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 52,128 bottles.

View original FDA notice →

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