Oxycodone and Acetaminophen CII Tablets USP — Class II drug recall D-0255-2026
Ongoing recall by SpecGx, LLC, reported 2026-01-14, distributed nationwide. Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
| Recall number | D-0255-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpecGx, LLC, Webster Groves, MO, United States |
| Recall initiated | 2025-12-16 |
| Classified | 2026-01-07 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 74,544 bottles |
| NDC | 00406-0512, 00406-0512-01, 00406-0512-05, 00406-0512-23, 00406-0512-62, 00406-0512-91, 00406-0522, 00406-0522-01, 00406-0522-05, 00406-0522-23, 00406-0522-62, 00406-0523, 00406-0523-01, 00406-0523-05, 00406-0523-23, 00406-0523-62 |
| Lot numbers | 0522J23493 |
| Expiration dates | 2027-03 |
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 for recall
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0255-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.