Shoolin Pharma Chem LLP recalls SILDENAFIL CITRATE USP
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Aug 3, 2026
- Reported
- Aug 19, 2026
- Distribution
- Distributed Nationwide in the USA
- Status
- Ongoing
- Quantity
- 25KG, 250-1gm bags
- Lot / codes
- Batch SDC2505001, Date of Expiry: April 30, 2030.
- Company location
- Kadi
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0759-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0759-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.