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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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.

The Hazard

The recall stems from a failure in tablet specification. Tablets may be missing the imprint, complicating identification and leading to potential medication errors.

Reported Incidents

No injuries have been reported related to this recall. The potential for medication errors remains a significant concern due to missing imprints.

What to Do

Stop using the recalled tablets immediately. Consumers should contact SpecGx, LLC or their healthcare provider for further guidance. The notification method is via email.

Contact Information

For more information, consumers can visit the FDA's website or contact SpecGx directly at their customer service.

Key Facts

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

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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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