Reported Aug 19, 2026 · Ongoing · Updated Aug 25, 2026
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem…
Shoolin Pharma Chem LLP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shoolin Pharma Chem LLP · 408 B/H Ratnamani Tubes · Kadi · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Batch SDC2505001
- Date of Expiry
April 302030
- Amount recalled
- 25KG, 250-1gm bags
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations:Noted during FDA inspection
This product could cause temporary or reversible health problems — stop using it.
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