FDAHealthAugust 3, 2026
Shoolin Pharma Chem LLP — 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, I
⚠️ CGMP Deviations:Noted during FDA inspection
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 3, 2026
Distributed Nationwide in the USA
What's affected?
- Product
- 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
- Lot code
- Batch TLF2506001, Date of Expiry: May 31, 2028.
Additional details
Batch TLF2506001, Date of Expiry: May 31, 2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1KG - 20 X 1KG(1000gm) bags.
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