FDA-Drug2026-08-19Class IIPROCESSING DEFECT
Shoolin Pharma Chem sildenafil citrate USP recalled for CGMP deviations
What this means
The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP, a supplier of sildenafil citrate USP—an active pharmaceutical ingredient used in prescription compounding. One lot (SDC2505001) distributed nationwide has been recalled due to these manufacturing control issues.
- If you are a pharmacy or compounding facility that received this lot, stop using it and contact your supplier for instructions.
- Do not dispense or compound medications using this material.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
Hazard
CGMP Deviations:Noted during FDA inspection
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
25 KG, 25 X 1.00 KG bags
Manufactured in
408 B/H Ratnamani Tubes, Block/Survey No; Nr Maruti Inox, Kadi, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0763-2026More Shoolin Pharma Chem recalls
- FDA-Drug2026-08-19Shoolin Pharma Chem tadalafil USP powder recalled for CGMP manufacturing deviations
- FDA-Drug2026-08-19Shoolin Pharma Chem tadalafil USP powder recalled for CGMP manufacturing deviations
- FDA-Drug2026-08-19Shoolin Pharma Chem LLP tadalafil USP recalled for CGMP deviations
- FDA-Drug2026-08-19Shoolin Pharma Chem sildenafil citrate recalled for CGMP manufacturing deviations
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