FDA-Drug2025-12-17Class II
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lupin Pharmaceuticals Inc.
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-0227-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief