Oxycodone and Acetaminophen Recall: SpecGx 7.5/325
Announced 2026-01-14 · FDA
The recall covers SpecGx LLC Oxycodone and Acetaminophen CII tablets, 7.5 mg/325 mg, Rx only, in 100-count bottles (NDC 0406-0522-01), Lot 0522J23493, Exp 03/2027, distributed nationwide, affecting 74,544 bottles. The recall is due to a potential for the imprint to be missing on tablets.
| Brand | SpecGx, LLC |
|---|---|
| Product | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 |
| Reason | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. |
| Severity | moderate |
| Units affected | 287988 |
| Distribution | Nationwide |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not take or use this medication.
- Check your bottle for Lot 0522J23493 and expiration 03/2027; if matched, set aside and do not consume.
- Contact your pharmacist or healthcare provider for guidance and possible replacement.
- Follow local disposal instructions for recalled medicines.
How to identify the recalled item
| Lot / date codes | Lot: 0522J23493, expires: 03/2027. |
|---|---|
| Lot / date codes | Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.