FDA-Drug2026-08-19Class IIPROCESSING DEFECT
Shoolin Pharma Chem tadalafil USP powder 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. The company manufactures tadalafil USP powder (active pharmaceutical ingredient) intended for prescription compounding use. One batch (TLF2506001, expiring May 31, 2028) totaling 20 kg was distributed nationwide in the USA.
- If you are a licensed pharmacy or compounding facility that received this batch, quarantine it immediately and do not use it.
- Contact Shoolin Pharma Chem LLP or your supplier for instructions on return or disposal.
- Verify any compounded medications made from this batch and consult with the prescribing physician if concerned.
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
20 KG, 40 X 0.500KG(500gm) bags
Manufactured in
408 B/H Ratnamani Tubes, Block/Survey No; Nr Maruti Inox, Kadi, India
Products
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, 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 171596-29-5), NDC 85702-002-04.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0761-2026More 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 LLP tadalafil USP recalled for CGMP deviations
- FDA-Drug2026-08-19Shoolin Pharma Chem sildenafil citrate recalled for CGMP manufacturing deviations
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