HIGH

Mylan Haloperidol Lactate Injection Recalled Over Labeling Errors

Mylan Institutional LLC recalled 800 vials of Haloperidol Lactate Injection on October 10, 2025, due to incorrect RFID tag labels. The product may pose a risk due to potential mislabeling affecting tracking and administration. Healthcare providers should stop using the product immediately and follow up with Safecor Health for guidance.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
HALOPERIDOL LACTATE, Mylan Institutional LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Safecor Health, LLC or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

Haloperidol Lactate Injection is an antipsychotic medication used for treating various mental health conditions. Healthcare providers administer it intramuscularly, typically in clinical settings.

Why This Is Dangerous

Incorrect RFID tags can result in challenges in tracking medication, potentially leading to misadministration or improper patient treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face safety risks if the medication is misused due to labeling errors, emphasizing the importance of accurate medication tracking.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on your Haloperidol Lactate vials.
  2. Ensure it matches Lot 25381993 or Lot 25391516.
  3. Verify the expiration date is December 31, 2026.

Where to find product info

The lot number and expiration date can be found printed on the vial or packaging.

What timeline to expect

Expect a refund or replacement processing timeline of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • If Safecor Health does not respond promptly, consider escalating the issue through your healthcare provider.
  • Document all communication attempts for your records.

How to prevent similar issues

  • Always check labels and packaging for accuracy before using medications.
  • Stay informed about recalls and safety notices for medications you use.

Documentation advice

Keep records of your purchase, including receipts, communication with the manufacturer, and any medical advice received.

Product Details

The recall involves Haloperidol Lactate Injection, 5 mg/mL, packaged in 25 x 1 mL single-dose vials. The affected lot numbers are 25381993 and 25391516, with an expiration date of December 31, 2026. The product was distributed in Massachusetts.

Key Facts

  • Recall date: October 10, 2025
  • 800 vials affected
  • Distributed in Massachusetts
  • Incorrect RFID labels applied
  • Stop use immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeHaloperidol Lactate Injection
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot 25381993 and 25391516
Exp 12/31/2026
UPC Codes
67457-426
67457-426-00
67457-426-12
Affected States
MA
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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