FDAFDA · Food and drugs·Recall number D-0760-2026
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.
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
- Lot: TLF2506001, Date of Expiry: May 31, 2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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