Shoolin Pharma Chem LLP

FDA Regulatory Profile

Shoolin Pharma Chem LLP appears in FDA public data with 5 recalls, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0759-2026, Class II) was initiated on August 3, 2026.

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0759-2026Class IISILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", ShAugust 3, 2026
D-0760-2026Class IITADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin PhAugust 3, 2026
D-0763-2026Class IISILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", ShAugust 3, 2026
D-0762-2026Class IITADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin PharAugust 3, 2026
D-0761-2026Class IITADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin August 3, 2026