Moderate riskFDA DrugClass II

SpecGx oxycodone-acetaminophen recalled for possible missing imprint

SpecGx LLC is recalling certain bottles of oxycodone and acetaminophen 10mg/325mg tablets because some tablets may be missing the imprint (marking). This could make it difficult to identify the medication. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if your bottle matches lot 0523J23904 (expires 05/2027), 0523J24426, or 0523J24427 (expires 06/2027).
  2. If you have one of these lots, contact your pharmacy or prescriber before taking any more tablets.
  3. Do not use tablets that are missing an imprint.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
287,988 Bottles.
Illnesses reported
None reported
Manufactured in
385 Marshall Ave, Webster Groves, MO, United States
Classification
Class II
Recall number
D-0254-2026

In the FDA's words

Description
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027. Distribution: Nationwide Affected quantity: 287,988 Bottles.
Hazard
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

2 products in this recall

The agency lists each product separately. Check every one you might have.

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