Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webst...
FDA Recall #D-0254-2026 — Class II — December 16, 2025
Product Description
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.
Recalling Firm
SpecGx, LLC — Webster Groves, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
287,988 Bottles.
Distribution
Nationwide
Code Information
Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated