Recall: D-0759-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-03Initiated

OngoingStatus

Shoolin Pharma Chem LLPFirm

Product

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-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, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

Reason

CGMP Deviations:Noted during FDA inspection

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.