Par Health USA, LLC

FDA Regulatory Profile

Par Health USA, LLC appears in FDA public data with 1 recall, 0 510(k) clearances, 17 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0596-2026, Class II) was initiated on June 12, 2026.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
17
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0596-2026Class IIBuprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For IJune 12, 2026