Oxaydo Tablet
FDA Recall NDC 69344-113
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 Oxaydo (NDC 69344-113). A significant event, classified as Class III, was initiated on Oct 20, 2023 by Zyla Life Sciences Us Llc. The reported reason for this action was: "Sub-potent Drug: Lower potency than labeled."
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 III Ongoing
Sub-potent Drug: Lower potency than labeled.
Oct 20, 2023
Nov 15, 2023
3,792 bottles
Recall Profile & Regulatory Data
Event ID
93254
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Zyla Life Sciences US Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Batch or Lot Expiration Information
Lot# Lot 22W02, Exp 01/31/2025
Affected Packages Involved in this Recall
69344-113-11Product
69344-213-11Product
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.
