FDA-Drug2026-08-19Class IIPROCESSING DEFECT
Shoolin Pharma Chem tadalafil USP powder recalled for CGMP manufacturing deviations
What this means
The FDA identified manufacturing practice violations (CGMP deviations) during an inspection of Shoolin Pharma Chem's facility in India. One batch of tadalafil USP powder used for prescription compounding was distributed nationwide in the USA and does not meet required manufacturing standards.
- If you are a pharmacy or compounding facility, check your inventory for batch TLF2506001 (expiry May 31, 2028).
- Contact your supplier or the FDA for instructions on affected product disposition.
- Do not use this batch for compounding.
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
1KG - 20 X 1KG(1000gm) bags
Manufactured in
408 B/H Ratnamani Tubes, Block/Survey No; Nr Maruti Inox, Kadi, India
Products
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-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 85702-001-08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0762-2026More Shoolin Pharma Chem recalls
- 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
- FDA-Drug2026-08-19Shoolin Pharma Chem sildenafil citrate recalled for CGMP manufacturing deviations
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