FDA DrugsClass II
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, ...
Published: January 14, 2026Recall ID: D-0254-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Product Description & Identification
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Webster Groves |
| State | MO |
| Openfda › Upc › 1 | 0304060522053 |
| Openfda › Upc › 2 | 0304060523050 |
| Openfda › Upc › 3 | 0304060512054 |
| Openfda › Unii › 1 | 362O9ITL9D |
| Openfda › Unii › 2 | C1ENJ2TE6C |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1049214 |
| Openfda › Rxcui › 2 | 1049221 |
| Openfda › Rxcui › 3 | 1049225 |
| Openfda › Spl id | 38cc2423-8e75-4007-b224-75aa920582d7 |
| Openfda › Brand name | OXYCODONE AND ACETAMINOPHEN |
| Openfda › Spl set id | f2137f1a-b49a-40bd-97ac-cd6b36e295f4 |
| Openfda › Package ndc › 1 | 0406-0512-01 |
| Openfda › Package ndc › 2 | 0406-0512-05 |
| Openfda › Package ndc › 3 | 0406-0512-62 |
| Openfda › Package ndc › 4 | 0406-0512-23 |
| Openfda › Package ndc › 5 | 0406-0512-91 |
| Openfda › Package ndc › 6 | 0406-0522-01 |
| Openfda › Package ndc › 7 | 0406-0522-62 |
| Openfda › Package ndc › 8 | 0406-0522-05 |
| Openfda › Package ndc › 9 | 0406-0522-23 |
| Openfda › Package ndc › 10 | 0406-0523-01 |
| Openfda › Package ndc › 11 | 0406-0523-62 |
| Openfda › Package ndc › 12 | 0406-0523-05 |
| Openfda › Package ndc › 13 | 0406-0523-23 |
| Openfda › Product ndc › 1 | 0406-0512 |
| Openfda › Product ndc › 2 | 0406-0522 |
| Openfda › Product ndc › 3 | 0406-0523 |
| Openfda › Generic name | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name › 1 | ACETAMINOPHEN |
| Openfda › Substance name › 2 | OXYCODONE HYDROCHLORIDE |
| Openfda › Manufacturer name | SpecGx LLC |
| Openfda › Application number | ANDA087463 |
| Openfda › Is original packager | true |
| Event id | 98136 |
| Address 1 | 385 Marshall Ave |
| Code info | Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027. |
| Postal code | 63119-1831 |
| Report date | 20260114 |
| Product type | Drugs |
| Product quantity | 287,988 Bottles. |
| Reason for recall | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Initial firm notification | |
| Center classification date | 20260107 |
Overview
- Recalling FirmSpecGx, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide