D-0227-2026Class II

Lupin Pharmaceuticals Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-12-17

Distribution

Nationwide.

Firm state

Product quantity

52,128 bottles

Initiated by

Voluntary: Firm initiated

Reason for recall

Defective container - seal not adhering to bottles

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.

Code / lot info

Lot # QB00865, exp. date Feb 2028

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →