FDA recall D-0762-2026

Shoolin Pharma Chem LLP · Class II · drug

Product

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

Reason for recall

CGMP Deviations:Noted during FDA inspection

Distribution

Distributed Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2026-08-03
Report date: 2026-08-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kadi, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0762-2026