Recall
FDAHealthAugust 3, 2026

Shoolin Pharma Chem LLP — SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maru

⚠️ CGMP Deviations:Noted during FDA inspection

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
August 3, 2026

Distributed Nationwide in the USA

What's affected?

Product
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-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, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
Lot code
Batch SDC2505001, Date of Expiry: April 30, 2030.

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 25KG, 250-1gm bags.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.