FDA-Drug2026-08-19Class IIPROCESSING DEFECT
Shoolin Pharma Chem sildenafil citrate recalled for CGMP manufacturing deviations
What this means
The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP's facility in India. Sildenafil citrate bulk powder (batch SDC2505001, expiring April 30, 2030) distributed nationwide for prescription compounding did not meet required manufacturing standards.
- If you are a pharmacy or compounding facility, do not use sildenafil citrate from batch SDC2505001.
- Contact your supplier or the FDA for guidance on affected inventory.
- Consult the FDA's full recall notice for specific lot numbers and distribution details.
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
25KG, 250-1gm bags
Manufactured in
408 B/H Ratnamani Tubes, Block/Survey No; Nr Maruti Inox, Kadi, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0759-2026More Shoolin Pharma Chem recalls
- FDA-Drug2026-08-19Shoolin Pharma Chem tadalafil USP powder recalled for CGMP manufacturing deviations
- FDA-Drug2026-08-19Shoolin Pharma Chem sildenafil citrate USP recalled for CGMP 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
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