OXYCODONE AND ACETAMINOPHEN
Recalling Firm / Manufacturer: SpecGx, LLC
(Webster Groves, MO, United States)
FDA Recall Number: D-0255-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
OXYCODONE AND ACETAMINOPHEN
Generic Name
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Active Substance(s)
Oxycodone Hydrochloride, Acetaminophen
Administration Route
Oral
National Drug Code (NDC)
0406-0512
Total Quantity Recalled
74,544 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
January 14, 2026
Firm Initiation Date
December 16, 2025
FDA Classification Date
Jan 07, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: 0522J23493, expires: 03/2027.
Distribution Information
Geographic scope of affected shipments
Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0255-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC