Shoolin Pharma Chem Llp: Tadalafil Usp, 0
Recall Summary Shoolin Pharma Chem LLP is recalling tadalafil powder (a prescription compounding ingredient) distributed nationwide because the FDA found manufacturing violations during an inspection. The product was sold to pharmacies and other facilities that compound prescription medications for patients.
- Recalling firm
- Shoolin Pharma Chem LLP
- Product
- 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.
- Reason
- CGMP Deviations:Noted during FDA inspection
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-03
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distributed Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/61c6b0b9-b6a9-44bf-b383-341942140281