PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 14, 2026 Initiated: December 16, 2025 #D-0254-2026

Product Description

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

Reason for Recall

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

Details

Recalling Firm
SpecGx, LLC
Units Affected
287,988 Bottles.
Distribution
Nationwide
Location
Webster Groves, MO

Frequently Asked Questions

What product was recalled?
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 SpecGx, LLC. Units affected: 287,988 Bottles..
Why was this product recalled?
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 14, 2026. Severity: Moderate. Recall number: D-0254-2026.