FDA recall D-0227-2026

Product

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

Distribution

Nationwide.

Key facts

Status

Ongoing

Initiation date

2025-11-05

Report date

2025-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2026