HIGH

SpecGx Recalls Oxycodone and Acetaminophen Tablets Due to Missing Imprint

SpecGx LLC recalled 287,988 bottles of Oxycodone and Acetaminophen tablets on December 16, 2025. The tablets may lack proper imprinting, posing risks for misuse and confusion. Healthcare providers and consumers must stop using the product immediately and seek guidance.

Quick Facts at a Glance

Recall Date
December 16, 2025
Hazard Level
HIGH
Brands
SpecGx LLC, OXYCODONE AND ACETAMINOPHEN
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact SpecGx, LLC or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

Oxycodone and Acetaminophen tablets are commonly prescribed for pain relief. Consumers buy this medication to manage moderate to severe pain, often after surgery or injury.

Why This Is Dangerous

The hazard arises from the potential missing imprint on the tablets, which can lead to confusion in identifying the medication. This can result in accidental misuse or overdose, particularly if patients are not aware of the missing imprint.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall affects consumers who may have purchased the medication for pain relief. The urgency lies in the potential for misuse, which could lead to serious health risks.

Practical Guidance

How to identify if yours is affected

  1. Verify the lot numbers on your medication bottle: 0523J23904, 0523J24426, 0523J24427.
  2. Check for the imprint on each tablet; if missing, the product is affected.
  3. Look for the expiration dates; affected products expire between May 2027 and June 2027.

Where to find product info

Lot numbers and expiration dates can typically be found on the label of the product packaging.

What timeline to expect

Expect 4-6 weeks for refund processing after contacting SpecGx, LLC.

If the manufacturer is unresponsive

  • Follow up with SpecGx via email or phone for updates.
  • Document all correspondence for your records.

How to prevent similar issues

  • Look for proper imprinting on tablets when purchasing medications in the future.
  • Consult your healthcare provider for safer alternatives if imprinting is unclear.
  • Ensure you buy medications from reputable pharmacies.

Documentation advice

Keep records of your purchase, including receipts and photos of the product.

Product Details

The recalled product is Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, packaged in bottles of 100 tablets. The affected lot numbers include 0523J23904, 0523J24426, and 0523J24427, with expiration dates ranging from May 2027 to June 2027. The product was distributed nationwide.

Key Facts

  • 287,988 bottles recalled
  • Potential for missing tablet imprint
  • Class II recall status
  • Distributed nationwide
  • Contact SpecGx for guidance

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot: 0523J23904
0523J24426
0523J24427
UPC Codes
0406-0512
0406-0522
0406-0523
+10 more
Affected States
ALL
Report Date
January 14, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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