RecallWatchUSA

Home / Recalls / Drugs

Shoolin Pharma Chem LLP recalls SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LL

Recalled August 19, 2026 · FDA recall D-0763-2026 · Shoolin Pharma Chem LLP

Hazard
CGMP Deviations:Noted during FDA inspection · FDA Class II
Units
25 KG, 25 X 1.00 KG bags
Sold at
Distributed Nationwide in the USA

Description

CGMP Deviations:Noted during FDA inspection

Product
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-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, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) 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 SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LL | RecallWatchUSA