Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-17
Distribution
Nationwide.
Firm state
FL
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 openFDA enforcement API. 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.