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Medium risk Drugs & MedicationsClass II

SpecGx Oxycodone Acetaminophen Recall

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

Updated December 16, 2025

SpecGx is recalling Oxycodone and Acetaminophen tablets (10 mg / 325 mg) because some tablets may be missing the imprint, making it impossible to verify the medication. This could lead to dosing confusion or accidental misuse.

Is the SpecGx, LLC recalled? Yes. This product was recalled by FDA on December 16, 2025. Details below.

What is recalled

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

Am I affected

You're affected if you have a prescription bottle of Oxycodone and Acetaminophen tablets labeled 10 mg / 325 mg with NDC 0406-0523-01 from SpecGx. Check the tablets: if any are missing an imprint (text/marking on the tablet surface), they are part of this recall.

What to do right now

Contact your pharmacy or the manufacturer to report the affected medication and obtain a replacement. Do not use tablets with missing imprints, as you cannot verify what you are taking.

The hazard

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

Brands affected

SpecGx, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0254-2026
Classification
Class II
Recalled
December 16, 2025
Read the official notice

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