CLASS II ONGOING Drug recall · Reported 14 Jan 2026 · FDA Enforcement Report
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalled
SpecGx is recalling Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, distributed nationwide in the US. The recall was initiated on 16 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0254-2026
- FDA event ID
- 98136
- Recalling firm
- SpecGx, Webster Groves, MO
- Manufacturer
- SpecGx LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2025
- FDA classified
- 7 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 16 Dec 2025 | Recall initiated by company | |
| 7 Jan 2026 | Classified by FDA | +22 days |
| 14 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Product as listed by the FDA
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Where it was distributed
Nationwide
Questions about this recall
Is Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalled?
Yes. SpecGx recalled Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg on 16 Dec 2025. The recall is Class II and its status is Ongoing. Recall number D-0254-2026.
Why was it recalled?
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Which lots are affected?
Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SpecGx
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
Other Oxycodone Hydrochloride recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |