Oxycodone and Acetaminophen CII Tablets USP recall (SpecGx, LLC)
DrugClass IIOngoing
Summary: SpecGx, LLC is recalling Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.. Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
What is being recalled
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Why
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide
How to tell if yours is affected
Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0254-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 16, 2025 |
| Reported | January 14, 2026 |
| Company | SpecGx, LLC |
| Company location | Webster Groves, MO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 287,988 Bottles. |
More recalls from SpecGx, LLC · all drug recalls · recalls from December 2025