Warning
Shoolin Pharma Chem LLP Recalls SILDENAFIL CITRATE USP
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0759-2026Drug / Pharmaceutical
Shoolin Pharma Chem LLP Recalls SILDENAFIL CITRATE USP
Shoolin Pharma Chem LLP · Class II — Moderate Risk
Product Description
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
Reason for Recall
CGMP Deviations:Noted during FDA inspection
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Distributed Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Shoolin Pharma Chem LLP has recalled a pharmaceutical product that the FDA classified as Class II affecting 25KG, 250-1gm bags. The recall was initiated on August 3, 2026. CGMP Deviations:Noted during FDA inspection. It was distributed in Distributed Nationwide in the USA. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.