FDA-Drug2025-12-17Class IIPACKAGING DEFECT
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
TAMPERINGNationwide distribution
Hazard
Defective container - seal not adhering to bottles
Sold states
Nationwide.
Affected count
52,128 bottles
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Products
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2026More Lupin Pharmaceuticals Inc. recalls
- FDA-Drug2026-07-08Lupin Pharmaceuticals prednisolone acetate eye drops recalled for foreign substance contamination
- FDA-Drug2026-07-08Lupin Glucagon Emergency Kit recalled for syringe plunger functionality defect
- FDA-Drug2026-05-27Lupin Liraglutide Injection recalled for particulate matter in cartridges
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