Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Web...
FDA Recall #D-0255-2026 — Class II — December 16, 2025
Product Description
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
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
74,544 bottles
Distribution
Nationwide
Code Information
Lot: 0522J23493, expires: 03/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated