The Recall Desk
ModerateFDA (Drugs)·D-0254-2026·Announced 2026-01-14

Oxycodone and acetaminophen 10 mg tablets recalled over a missing imprint

SpecGx is recalling 287,988 bottles of Oxycodone and Acetaminophen CII Tablets, 10 mg/325 mg, because of the potential for the imprint to be missing on tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 under the minor labeling criterion: the record cites a potentially missing tablet imprint with no stated clinical consequence or reported harm.

Plain-English summary

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, from SpecGx LLC of Webster Groves, Missouri, under NDC 0406-0523-01, are being recalled.

The reason given in the enforcement record is a failed tablet specification: there is a potential for the imprint to be missing on tablets.

The recall covers 287,988 bottles from lot 0523J23904, expiring 05/2027, and lots 0523J24426 and 0523J24427, expiring 06/2027. Distribution was nationwide. The FDA has classified the action as Class II.

The imprint is how a tablet is identified. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.

The recalled product

Product
OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN)
Brand
OXYCODONE AND ACETAMINOPHEN
Manufacturer
SpecGx, LLC
Category
Drug — Opioid analgesic
Hazard
Affected units
287,988

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot: 0523J23904
  • expires: 05/2027
  • 0523J24426
  • 0523J24427
  • expires: 06/2027.

UPCs (3)

  • 0304060522053
  • 0304060523050
  • 0304060512054

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by SpecGx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · OXYCODONE AND ACETAMINOPHEN

Same hazard · missing imprint

See all →