FDAFDA · Food and drugs·Recall number D-0763-2026
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.
Published August 19, 2026 · Recall initiated: August 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations:Noted during FDA inspection
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Shoolin Pharma Chem LLP
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot: SDC2505001, Date of Expiry: April 30, 2030.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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