Class IIReported 2025-12-17

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

Recalled by Lupin Pharmaceuticals Inc.

Reason for Recall

Defective container - seal not adhering to bottles

Recall Number

D-0227-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-11-05

Reported

2025-12-17

Distribution

Nationwide.

Code Info

Lot # QB00865, exp. date Feb 2028

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.