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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SpecGx LLC, OXYCODONE AND ACETAMINOPHEN
- Product type
- Oxycodone and Acetaminophen Tablets
- Model numbers
- Lot: 0523J23904, 0523J24426, 0523J24427
- UPC codes
- 0406-0512, 0406-0522, 0406-0523, 0406-0512-01, 0406-0512-05, 0406-0512-62, 0406-0512-23, 0406-0512-91 +5 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 16, 2025
Reported by FDA DRUG
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify the lot numbers on your medication bottle: 0523J23904, 0523J24426, 0523J24427.
- Check for the imprint on each tablet; if missing, the product is affected.
- 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.
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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
- Potential for missing tablet imprint
- Class II recall status
- Contact SpecGx for guidance
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Safety Guide
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