TADALAFIL USP recall (Shoolin Pharma Chem LLP)
DrugClass IIOngoing
Summary: Shoolin Pharma Chem LLP is recalling 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.
What is being recalled
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.
Why
CGMP Deviations:Noted during FDA inspection
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Distributed Nationwide in the USA
How to tell if yours is affected
Batch TLF2506001, Date of Expiry: May 31, 2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0761-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 3, 2026 |
| Reported | August 19, 2026 |
| Company | Shoolin Pharma Chem LLP |
| Company location | Kadi, India |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20 KG, 40 X 0.500KG(500gm) bags |
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