Warning
Lupin Pharmaceuticals Inc. Recalls Sertraline Hydrochloride Tablets USP
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0227-2026Drug / Pharmaceutical
Lupin Pharmaceuticals Inc. Recalls Sertraline Hydrochloride Tablets USP
Lupin Pharmaceuticals Inc. · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Lupin Pharmaceuticals Inc. has recalled a pharmaceutical product that the FDA classified as Class II affecting 52,128 bottles. The recall was initiated on November 5, 2025. Defective container - seal not adhering to bottles. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.