FDA recall D-0759-2026

Shoolin Pharma Chem LLP · Class II · drug

Product

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

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-0759-2026