FDA-Drug2026-01-14Class IIPACKAGING DEFECT
SpecGx oxycodone/acetaminophen tablets recalled for missing imprint
What this means
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.
The agency's original wording
Hazard
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Intended for
Adults
Illnesses reported
None reported
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-0254-2026Want us to check the next one for you?
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