SpecGx, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
26
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0255-2026Class IIOxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, WebsteDecember 16, 2025
D-0254-2026Class IIOxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster December 16, 2025