← FDA ENFORCEMENT
D-0763-2026Class II

Shoolin Pharma Chem LLP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Shoolin Pharma Chem LLP
Product type
Drug
Status
Ongoing
Report date
2026-08-19
Distribution
Distributed Nationwide in the USA
Product quantity
25 KG, 25 X 1.00 KG bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations:Noted during FDA inspection

Product description

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.

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →