Specialty Process Labs LLC

FDA Regulatory Profile

Specialty Process Labs LLC appears in FDA public data with 3 recalls, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0294-2026, Class II) was initiated on January 16, 2026.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0294-2026Class IIThyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, SpeciaJanuary 16, 2026
D-0446-2024Class IIS.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, SpMarch 1, 2024
D-0447-2024Class IIS.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty PrMarch 1, 2024