FDAFDA · Food and drugs·Recall number D-0762-2026
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
Published August 19, 2026 · Recall initiated: August 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations:Noted during FDA inspection
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Shoolin Pharma Chem LLP
- Distributor
- Distributed Nationwide in the USA
- Lot
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.