Oxycodone and Acetaminophen CII Tablets USP recall
FDA recall D-0255-2026 · initiated Dec 16, 2025
SpecGx, LLC recalled Oxycodone and Acetaminophen CII Tablets USP in Dec 2025 — an FDA Class II recall (D-0255-2026) because Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 74,544 bottles
Details
- 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
- Recalling company
- Specgx LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Dec 16, 2025
- FDA report date
- Jan 14, 2026
Frequently asked
- Was Oxycodone and Acetaminophen CII Tablets USP recalled?
- SpecGx, LLC recalled Oxycodone and Acetaminophen CII Tablets USP in Dec 2025 — an FDA Class II recall (D-0255-2026) because Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Oxycodone and Acetaminophen CII Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0255-2026 was: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
- Is a recalled Oxycodone and Acetaminophen CII Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Oxycodone and Acetaminophen CII Tablets USP are affected?
- Distributed: Nationwide. The recall covers these lots — Lot: 0522J23493, expires: 03/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0255-2026.