FDAHealthDecember 16, 2025
SpecGx, LLC — Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
⚠️ Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 16, 2025
Nationwide
What's affected?
- Product
- Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
- UPC
- 0304060522053
- Lot code
- 0523J23904
Additional details
Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 287,988 Bottles..
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