Shoolin Pharma Chem Llp: Tadalafil Usp, 1
Shoolin Pharma Chem LLP is recalling tadalafil powder (used by pharmacies to compound prescription medications) distributed nationwide because the FDA found manufacturing quality control problems during an inspection. The recall affects a 1-kilogram bag of the active ingredient distributed across all U.S. states. This is a Class II recall, indicating a potentially serious issue.
- Recalling firm
- Shoolin Pharma Chem LLP
- 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
- 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/91c08ee8-b7ab-4017-9c42-e0a5530ed347