FDA recall, , Moderate risk
SpecGx Oxycodone and Acetaminophen CII Tablets
Oxycodone and Acetaminophen CII Tablets may have a missing imprint on the tablets.
Summary by Recall Canary from the FDA notice
What happened
SpecGx, LLC of Webster Groves, Missouri is recalling Oxycodone and Acetaminophen CII Tablets USP because the imprint may be missing on tablets. The recall, which began December 16, 2025, was added to the FDA's Enforcement Report on January 7, 2026, and covers nationwide distribution. The affected products include the 10mg/325 mg and 7.5 mg/325 mg strengths, each in 100-tablet bottles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Oxycodone and Acetaminophen CII Tablets USP
- Strength
- 10 mg
- NDC
- 0406-0523-01
- Lot code
- 0523J23904
- 0523J24426
- 0523J24427
- Strength
- 7.5 mg
- NDC
- 0406-0522-01
- 0406052201
- Lot code
- 0522J23493
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- SpecGx, LLCWebster Groves, Missouri
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98136
- Recall numbers
- D-0254-2026 to D-0255-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
