Shoolin Pharma Chem LLP recalls TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Blo
Recalled August 19, 2026 · FDA recall D-0761-2026 · Shoolin Pharma Chem LLP
Hazard
CGMP Deviations:Noted during FDA inspection · FDA Class II
Units
20 KG, 40 X 0.500KG(500gm) bags
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations:Noted during FDA inspection
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.
Manufacturer(s)
Shoolin Pharma Chem LLP
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →