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Drug FDA Class II Ongoing Mislabeling

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

SpecGx, LLC Published Jan 14, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SpecGx, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Missing Tablet Imprint · primary

Affected products (1)

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

OXYCODONE AND ACETAMINOPHEN · 74,544 bottles

NDC: 0406-0512, 0406-0522, 0406-0523, 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
Lot codes: 0522J23493
Code info: Lot: 0522J23493, expires: 03/2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 16, 2025
  2. Published
    Jan 14, 2026
Recall number
D-0255-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.