Shoolin Pharma Chem Llp: Tadalafil Usp, 0
Tadalafil USP Recall Summary Shoolin Pharma Chem LLP is recalling Tadalafil USP (a prescription compounding ingredient) distributed nationwide because the FDA found manufacturing process violations during an inspection. This recall affects pharmacies and compounding facilities across all U.S. states that received 500-gram bags of this product used to make prescription medications.
- Recalling firm
- Shoolin Pharma Chem LLP
- Product
- TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-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 85702-002-04.
- 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/9a41f6d9-c9b2-4ad5-8548-b4e0fabb1557