Methadone Hydrochloride Tablet
FDA Recall NDC 0054-0709
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 Methadone Hydrochloride (NDC 0054-0709). A significant event, classified as Class III, was initiated on Dec 19, 2024 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only."
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
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Dec 19, 2024
Jan 15, 2025
2591 100-count boxes
Recall Profile & Regulatory Data
Event ID
95999
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
West-Ward Columbus Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Batch or Lot Expiration Information
Lot# AC2556A; Exp. 03/2027
Affected Packages Involved in this Recall
0054-0709-25Product
0054-0709-20Product
0054-0710-25Product
0054-0710-20Product
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.
