FDA-Drug2026-08-19Class IIPROCESSING DEFECT
Shoolin Pharma Chem LLP tadalafil USP recalled for CGMP deviations
What this means
Shoolin Pharma Chem LLP's tadalafil USP powder (lot TLF2506001) was found to have deviations from good manufacturing practices during an FDA inspection. The affected product is a 100-gram bag intended for prescription compounding only.
- If you are a pharmacy or compounding facility that received this product, stop using it immediately.
- Contact Shoolin Pharma Chem LLP or your supplier for return or disposal instructions.
- Notify patients or practitioners who may have received compounded medications made from this batch.
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 - 100-0.1KG(100gm) bags
Manufactured in
408 B/H Ratnamani Tubes, Block/Survey No; Nr Maruti Inox, Kadi, India
Products
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-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 1715996-29-5), NDC 85702-002-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0760-2026More 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 sildenafil citrate recalled for CGMP manufacturing deviations
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