The Recall Desk
HighFDA (Drugs)·D-0255-2026·Announced 2026-01-14

Oxycodone-Acetaminophen Tablets Recalled for Missing Product Imprint

SpecGx, LLC is recalling 74,544 bottles of prescription oxycodone-acetaminophen tablets due to a potential manufacturing defect where the product imprint may be missing. Patients should contact their pharmacy or healthcare provider if they have affected bottles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (prescription medication) where injury has not yet been reported. A missing imprint on a controlled substance could lead to medication identification errors, but no illnesses or injuries have been documented in the source.

Plain-English summary

SpecGx, LLC is recalling 74,544 bottles of oxycodone and acetaminophen tablets (7.5 mg/325 mg) due to a failed tablet specification where the imprint may be missing from tablets. This defect was identified during manufacturing quality control.

A missing imprint on a prescription medication can affect medication identification and verification, which is particularly important for controlled substances like oxycodone. Without proper identification, patients and healthcare providers may have difficulty verifying the medication and dose.

The affected product is Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg in bottles of 100 tablets, manufactured by SpecGx LLC in Webster Groves, Missouri. The recall affects Lot 0522J23493, which expires 03/2027. The product was distributed nationwide.

Patients who have bottles from the affected lot should contact their pharmacy or healthcare provider. Do not discard medication without consulting a pharmacist or healthcare provider for proper disposal instructions.

The recalled product

Product
OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN)
Brand
OXYCODONE AND ACETAMINOPHEN
Manufacturer
SpecGx, LLC
Category
Drug — Prescription / Opioid
Hazard
  • missing-imprint

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 (2)

  • Lot: 0522J23493
  • expires: 03/2027.

UPCs (3)

  • 0304060522053
  • 0304060523050
  • 0304060512054

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · OXYCODONE AND ACETAMINOPHEN

Same category