Drug recall D-0227-2026

Class II Ongoing reported Dec 17, 2025

Product

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

Reason for recall

Defective container - seal not adhering to bottles

Lots and codes

Lot # QB00865, exp. date Feb 2028

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Naples, FL
Quantity
52,128 bottles
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
November 5, 2025

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