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Shoolin Pharma Chem LLP recalls TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/S

Recalled August 19, 2026 · FDA recall D-0762-2026 · Shoolin Pharma Chem LLP

Hazard
CGMP Deviations:Noted during FDA inspection · FDA Class II
Units
1KG - 20 X 1KG(1000gm) bags
Sold at
Distributed Nationwide in the USA

Description

CGMP Deviations:Noted during FDA inspection

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
Manufacturer(s)
Shoolin Pharma Chem LLP
Made in
India

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Shoolin Pharma Chem LLP recalls TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/S | RecallWatchUSA