FDA-Drug2026-01-14Class IIPACKAGING DEFECT

SpecGx oxycodone/acetaminophen tablets recalled for missing imprint

LABEL MIX UPNationwide distribution

Check your SpecGx oxycodone tablets

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.

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

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

Sold states
Nationwide
Affected count
287,988 Bottles.
Manufactured in
385 Marshall Ave, Webster Groves, MO, United States
Products
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

Official notice

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

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