SpecGx, LLC

FDA Regulatory Profile

SpecGx, LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 27 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0254-2026, Class II) was initiated on December 16, 2025.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
27
Compliance Actions
0

Recent Recalls

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