FDA Recall D-0254-2026
SpecGx, LLC · Webster Groves, MO
Class II Ongoing 149 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Reason for recall
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall record
- Recall number
D-0254-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2025-12-16
- Classified by FDA Center
- 2026-01-07
- FDA published
- 2026-01-14
- Recalling firm
- SpecGx, LLC
- Firm location
- Webster Groves, MO
Drug identification
- Brand name(s)
- OXYCODONE AND ACETAMINOPHEN
- Generic name(s)
- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
- Manufacturer(s)
- SpecGx LLC
- NDC(s)
0406-0512, 0406-0522, 0406-0523- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.