Class II

Drug Recall: 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, Gu

Shoolin Pharma Chem LLP · August 3, 2026

Reason for Recall

CGMP Deviations:Noted during FDA inspection

Product Description

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

Distribution

Distributed Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

1KG - 20 X 1KG(1000gm) bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0762-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.