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.
CGMP Deviations:Noted during FDA inspection
| Recalling firm | Shoolin Pharma Chem LLP |
|---|---|
| Reason | CGMP Deviations:Noted during FDA inspection |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | Aug 3, 2026 |
| Region | India |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 1KG - 100-0.1KG(100gm) bags |
| Code/Lot | Lot: TLF2506001, Date of Expiry: May 31, 2028. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0760-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0760-2026)
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