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Class II · ModerateActive recall

Oxycodone And Acetaminophen

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySpecGx LLC
Brand nameOXYCODONE AND ACETAMINOPHEN
Generic nameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE
Distributed by / forSpecGx, LLC
NDC0406-0523-01
Show the full FDA record
Full product labelOxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Recalling firmSpecGx, LLC
DistributionNationwide
Quantity287,988 Bottles.
Recall initiated2025-12-16
Report date2026-01-14
Recall completed—
Recall numberD-0254-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWebster Groves MO United States

Related

Acetaminophen recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.