Official recall notice
FDA DrugClass IINotable
Sildenafil Citrate USP Recall (Aug 2026)
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
- Recall date
- 2026-08-19
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
CGMP Deviations:Noted during FDA inspection
Product description
CGMP Deviations:Noted during FDA inspection
Affected products
Batch SDC2505001, Date of Expiry: April 30, 2030.