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
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
- OXYCODONE AND ACETAMINOPHEN, SpecGx LLC
- Product type
- Oxycodone and Acetaminophen Tablets
- Model numbers
- Lot: 0522J23493, expires: 03/2027.
- 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 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
- Check the lot number on your bottle to see if it is Lot: 0522J23493.
- Verify the expiration date to confirm it is before March 2027.
- 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.
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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.
Key Facts
- Recall date: December 16, 2025
- Lot number: 0522J23493
- Expiration date: March 2027
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Safety Guide
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