Oxycodone Hydrochloride Tablet
FDA Recall NDC 68084-968
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Oxycodone Hydrochloride (NDC 68084-968). A significant event, classified as Class II, was initiated on Jan 14, 2026 by American Health Packaging. The reported reason for this action was: "Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Jan 14, 2026
Feb 18, 2026
31,676 packages
Recall Profile & Regulatory Data
Event ID
98308
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Affected Packages Involved in this Recall
68084-354-11Product
68084-354-01Product
68084-968-11Product
68084-968-01Product
68084-975-11Product
68084-975-01Product
68084-983-11Product
68084-983-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
