FDA recall D-0254-2026

SpecGx, LLC · Class II · drug

Product

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

Reason for recall

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2025-12-16
Report date
2026-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Webster Groves, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0254-2026