FDA Drug recall D-0255-2026
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
- FDA Drug
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of 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 by Specgx, citing failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0255-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-16 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Specgx |
| Distribution | US |
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.
Identifiers
| ndc | 0406-0512-01 |
|---|---|
| ndc | 0406-0512-05 |
| ndc | 0406-0512-62 |
| ndc | 0406-0512-23 |
| ndc | 0406-0512-91 |
| ndc | 0406-0522-01 |
| ndc | 0406-0522-62 |
| ndc | 0406-0522-05 |
| ndc | 0406-0522-23 |
| ndc | 0406-0523-01 |
| ndc | 0406-0523-62 |
| ndc | 0406-0523-05 |
| ndc | 0406-0523-23 |
| ndc | 0406052201 |
| code_info | Lot: 0522J23493, expires: 03/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0255-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.