Drug recall D-0762-2026

Class II Ongoing reported Aug 19, 2026

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 for recall

CGMP Deviations:Noted during FDA inspection

Lots and codes

Batch TLF2506001, Date of Expiry: May 31, 2028.

Recall details

Recalling firm
Shoolin Pharma Chem LLP, Kadi
Quantity
1KG - 20 X 1KG(1000gm) bags
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
August 3, 2026