HIGH

SpecGx Recalls Oxycodone and Acetaminophen Tablets Over Missing Imprint

SpecGx LLC recalled 74,544 bottles of Oxycodone and Acetaminophen Tablets on December 16, 2025. The tablets may lack an imprint, raising serious identification issues. Consumers should stop using these medications immediately and contact their healthcare providers for guidance.

Quick Facts at a Glance

Recall Date
December 16, 2025
Hazard Level
HIGH
Brands
OXYCODONE AND ACETAMINOPHEN, SpecGx LLC
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 a combination prescription medication used to relieve moderate to severe pain. Consumers typically buy these medications for pain management after surgeries or injuries.

Why This Is Dangerous

The recall occurred due to a potential issue with the tablet imprint, which may be missing. This defect can lead to confusion and possible medication errors, as imprints are critical for identifying the medication correctly.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects many consumers who depend on these medications for pain relief. The urgency to stop using the product highlights the potential for serious medication errors.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on your bottle to see if it is Lot: 0522J23493.
  2. Verify the expiration date to confirm it is before March 2027.
  3. Inspect the tablets for any missing imprint.

Where to find product info

The lot number and expiration date are typically located on the label of the bottle or on the bottom of the packaging.

What timeline to expect

Expect a refund processing timeline of about 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document your correspondence with SpecGx.
  • Follow up with a phone call if you do not receive a timely response.
  • Consider filing a report with the FDA if issues persist.

How to prevent similar issues

  • Always verify the imprint on prescription medications before use.
  • Consult your healthcare provider if you have questions about your medications.
  • Report any discrepancies or concerns about medications to your pharmacist.

Documentation advice

Keep records of your refund request, including emails, receipts, and any communication with SpecGx.

Product Details

The recalled product is Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, sold in bottles of 100 tablets. The affected lot is 0522J23493, with an expiration date of March 2027. The product is distributed nationwide.

Key Facts

  • Recall date: December 16, 2025
  • Lot number: 0522J23493
  • Expiration date: March 2027
  • Nationwide distribution
  • 74,544 bottles recalled

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 TypeOxycodone and Acetaminophen Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot: 0522J23493
expires: 03/2027.
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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