Drug recall D-0763-2026

Class II Ongoing reported Aug 19, 2026

Product

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. 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. 171599-83-0) NDC 85702-001-08.

Reason for recall

CGMP Deviations:Noted during FDA inspection

Lots and codes

Lot: SDC2505001, Date of Expiry: April 30, 2030.

Recall details

Recalling firm
Shoolin Pharma Chem LLP, Kadi
Quantity
25 KG, 25 X 1.00 KG bags
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
August 3, 2026