Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin...
FDA Recall #D-0227-2026 — Class II — November 5, 2025
Product Description
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
Recalling Firm
Lupin Pharmaceuticals Inc. — Naples, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
52,128 bottles
Distribution
Nationwide.
Code Information
Lot # QB00865, exp. date Feb 2028
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated