Shoolin Pharma Chem Llp: Sildenafil Citrate Usp, 1
Recall Summary Shoolin Pharma Chem LLP is recalling sildenafil citrate powder (1 kg bags) used by pharmacies to compound prescription medications, distributed nationwide across all U.S. states. The recall was issued because the manufacturer failed to meet required quality and safety standards during an FDA inspection. This is a Class II recall, meaning the product could cause health problems.
- Recalling firm
- Shoolin Pharma Chem LLP
- 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.
- 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/705f5086-f519-45a2-b740-b2b316dd382a