Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP,…
Shoolin Pharma Chem LLP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shoolin Pharma Chem LLP · 408 B/H Ratnamani Tubes, Block/Survey No; Nr Maruti Inox · Kadi
Is this the product you have?
- 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.
- Lot codes and dates
- Batch TLF2506001
- Date of Expiry
May 312028
- Amount recalled
- 20 KG, 40 X 0.500KG(500gm) bags
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations:Noted during FDA inspection
This product could cause temporary or reversible health problems — stop using it.
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