OXYCODONE HYDROCHLORIDE
Recalling Firm / Manufacturer: Amerisource Health Services LLC
(Columbus, OH, United States)
FDA Recall Number: D-0338-2026
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 HYDROCHLORIDE
Generic Name
OXYCODONE HYDROCHLORIDE
Active Substance(s)
Oxycodone Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
68084-354
Total Quantity Recalled
31,676 packages
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Full Product Description
Packaging specifications and labeling details
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
February 18, 2026
Firm Initiation Date
January 14, 2026
FDA Classification Date
Feb 13, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
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-0338-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC