Recall: D-0227-2026

Class II - Potentially Harmful

Class IIClassification

2025-11-05Initiated

OngoingStatus

Lupin Pharmaceuticals Inc.Firm

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

Defective container - seal not adhering to bottles

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.