Recalls / Class II
Class IID-0254-2026
Product
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
- Brand name
- Oxycodone And Acetaminophen
- Generic name
- Oxycodone Hydrochloride And Acetaminophen
- Active ingredients
- Acetaminophen, Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 0406-0512, 0406-0522, 0406-0523
- FDA application
- ANDA087463
- Affected lot / code info
- Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Why it was recalled
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recalling firm
- Firm
- SpecGx, LLC
- Manufacturer
- SpecGx LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 385 Marshall Ave, Webster Groves, Missouri 63119-1831
Distribution
- Quantity
- 287,988 Bottles.
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-12-16
- FDA classified
- 2026-01-07
- Posted by FDA
- 2026-01-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0254-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.