FDAHealthDecember 16, 2025
SpecGx, LLC — Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 20
⚠️ 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, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
- UPC
- 0304060522053
- Lot code
- 0522J23493
Additional details
Lot: 0522J23493, expires: 03/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 74,544 bottles.
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