Lower risk Drug recall · FDA · Published December 16, 2025

SpecGx Oxycodone/Acetaminophen Tablets Recall: Missing Imprint Risk

SpecGx recalls 100-tablet opioid pain relief with possible missing tablet imprints. Consumers should check for missing imprints and contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0254-2026Drug SpecGx ›

Lower-risk recall

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Take action

Contact the company

Recalling firmSpecGx, LLC385 Marshall Ave · Webster Groves, MO 63119-1831

✎ GovInfoNow plain-language explainer

SpecGx is recalling opioid pain medication that may have missing tablet imprints. This could lead to confusion about the medication's identity, potentially causing incorrect use or safety issues. Read more at govinfonow.com/recall/31612-specgx-oxycodone-acetaminophen-tablets-recall-missing-imprint-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31612-specgx-oxycodone-acetaminophen-tablets-recall-missing-imprint-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0254-2026

Cite this page

“SpecGx Oxycodone/Acetaminophen Tablets Recall: Missing Imprint Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31612-specgx-oxycodone-acetaminophen-tablets-recall-missing-imprint-risk. Based on FDA recall #D-0254-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0254-2026%22&limit=1).

SpecGx, LLC voluntarily recalled Oxycodone and Acetaminophen CII Tablets USP due to a potential for missing tablet imprints, according to the FDA. The agency announced the Class II recall on December 16, 2025.

How to tell if you have it

Brand: SpecGx
Product: Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg
NDC: 0406-0523-01
Lot codes: 0523J23904 (expires 05/2027), 0523J24426, 0523J24427 (expires 06/2027)
Quantity: 287,988 bottles
Distribution: Nationwide

The hazard

The recall addresses a failed tablet specification where there is a potential for the imprint to be missing on the tablets. The FDA stated this defect poses a risk of medication error.

Context

GovInfoNow's records show other recent recalls of similar products include Unichem Recalls Doxazosin 4mg Tablets Due to Wrong ID Imprint (2026-01-21), Golden State Medical Supply Primidone Tablets Recall: Cross Contamination Risk (2026-04-27), and Lannett Primidone Tablets Recall: Cross Contamination Risk (2026-04-24). FDA's FAERS adverse-event database contains 12,027 adverse-event reports naming this product across all years, with 8,408 marked serious and 1,613 listing a death.

How to tell if you have this one

Check for missing imprints on the tablets. The product was sold with NDC 0406-0523-01 and lots 0523J23904 (expires 05/2027) or 0523J24426, 0523J24427 (expires 06/2027).

Brand
SpecGx
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0254-2026	Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.; Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.	287,988 Bottles.	0406-0512-01, 0406-0512-05, 0406-0512-62, 0406-0512-23, 0406-0512-91, 0406-0522-01, 0406-0522-62, 0406-0522-05, 0406-0522-23, 0406-0523-01, 0406-0523-62, 0406-0523-05, 0406-0523-23
D-0255-2026	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; Lot: 0522J23493, expires: 03/2027.	74,544 bottles	0406-0512-01, 0406-0512-05, 0406-0512-62, 0406-0512-23, 0406-0512-91, 0406-0522-01, 0406-0522-62, 0406-0522-05, 0406-0522-23, 0406-0523-01, 0406-0523-62, 0406-0523-05, 0406-0523-23, 0406052201

Based on the official FDA remedy

What to do — step by step

Check for Missing Imprint
Look for missing imprints on the tablets to identify if the product is recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

Dec 16, 2025Firm started the recall
Jan 7, 2026FDA classified it Class II
Jan 14, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31612-specgx-oxycodone-acetaminophen-tablets-recall-missing-imprint-risk">SpecGx Oxycodone/Acetaminophen Tablets Recall: Missing Imprint Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0254-2026 (December 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0254-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.