FDA recall D-0761-2026

Product

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-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 85702-002-04.

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-0761-2026