oxycodone and acetaminophendrugHigh PriorityActive

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

oxycodone and acetaminophen Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. recalled by FDA. Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

Plain-English Summary

oxycodone and acetaminophen Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. recalled by FDA. Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
December 16, 2025
Last reviewed by RecallRadar
March 4, 2026

What You Should Do

  1. 1## Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-
  2. 2Agency: FDA | Category: drug Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. What to do:
  3. 3Stop using the product if your lot/model matches.
  4. 4Check the FDA notice for specifics.
Open Official Recall NoticeGet Alerts for oxycodone and acetaminophen Devices

What's Being Recalled

Quoted source excerpt from the official notice.

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

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my oxycodone and acetaminophen device affected?

Check the affected models section on this page. The official notice currently lists Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027..

What is the remedy for this recall?

## Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. Agency: FDA | Category: drug Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: oxycodone and acetaminophen recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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Quick Info

Brand
oxycodone and acetaminophen
Category
drug
Source Agency
FDA
Announced
December 16, 2025
Country
US
Status
Active

Source & Verification

Sourced from FDA. Last reviewed March 4, 2026.

Official source
FDA
Announced by source
December 16, 2025
Last reviewed by RecallRadar
March 4, 2026

Official Resources

Use these primary sources for final eligibility and claim instructions.

Open Official Recall NoticeView official notice from FDA

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