Multi event Drug Recall Enforcement Report Class II voluntary initiated by SpecGx, LLC, originally initiated on 12-16-2025 for the product Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. The product was recalled due to failed tablet/capsule specification: there is a potential for the imprint to be missing on tablets.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0254-2026 | 12-16-2025 | 01-14-2026 | Class II | 287,988 Bottles. | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Ongoing |
| D-0255-2026 | 12-16-2025 | 01-14-2026 | Class II | 74,544 bottles | 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 | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0406-0512 | Oxycodone And Acetaminophen | Oxycodone Hydrochloride And Acetaminophen | Tablet | Oral | Specgx Llc | Human Prescription Drug |
| 0406-0522 | Oxycodone And Acetaminophen | Oxycodone Hydrochloride And Acetaminophen | Tablet | Oral | Specgx Llc | Human Prescription Drug |
| 0406-0523 | Oxycodone And Acetaminophen | Oxycodone Hydrochloride And Acetaminophen | Tablet | Oral | Specgx Llc | Human Prescription Drug |
