Haloperidol Lactate Injection, Solution
FDA Recall NDC 67457-426
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 Haloperidol Lactate (NDC 67457-426). A significant event, classified as Class II, was initiated on Oct 10, 2025 by Mylan Institutional Llc. The reported reason for this action was: "Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm."
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
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Oct 10, 2025
Dec 10, 2025
800 1mL vials
Recall Profile & Regulatory Data
Event ID
97977
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Safecor Health, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in Massachusetts
Product Description
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Batch or Lot Expiration Information
Lot# Lot 25381993 and 25391516, Exp 12/31/2026
Affected Packages Involved in this Recall
67457-426-00Product
67457-426-12Product
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.
