Shoolin Pharma Chem Llp: Sildenafil Citrate Usp, 0
Recall Summary Shoolin Pharma Chem LLP is recalling sildenafil citrate powder (a prescription compounding ingredient) distributed nationwide because the FDA found manufacturing practice violations during an inspection. The product was sold in 100-gram bags to compounding pharmacies across all U.S. states and Washington, D.C.
- Recalling firm
- Shoolin Pharma Chem LLP
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-03
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distributed Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/f59378da-7041-4f10-9c12-37cc9e1cd796