RecallRadar
ModerateReported January 14, 2026

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg

Recalled by SpecGx, LLC

Product image for 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
Product image via DailyMed (National Library of Medicine). It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

SpecGx, LLC has recalled Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 14, 2026 and was initiated on December 16, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, with approximately 74,544 bottles affected. The company behind the recall is SpecGx, LLC, based in Webster Groves, MO. The FDA describes the product as: “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”

Why was Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalled?

According to the FDA, the stated reason for the recall is: “Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.”

What should you do?

If you think you may have bought Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, compare it against the product description and identifying codes (Lot: 0522J23493, expires: 03/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact SpecGx, LLC or your local health authority.

About this recall

This recall was distributed in MO. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
January 14, 2026
Recall started
December 16, 2025
Distributed in
MO
What was recalled
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
Why it was recalled (as stated by the FDA)
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
How to identify the affected product
Lot: 0522J23493, expires: 03/2027.
Amount recalled
74,544 bottles

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalled?+

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

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0255-2026. Information last synced from the FDA on July 6, 2026.

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