Recall
FDAHealthAugust 3, 2026

Shoolin Pharma Chem LLP — 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 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, 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.
Lot code
SDC2505001

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 25 KG, 25 X 1.00 KG bags.

View original FDA notice →

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