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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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.

The Hazard

The recall stems from incorrect RFID tag labels applied by a repackaging firm. This mislabeling could lead to medication errors, potentially impacting patient safety.

Reported Incidents

No specific incidents or injuries linked to this recall have been reported. The issue primarily relates to potential tracking and administration errors.

What to Do

Stop using Haloperidol Lactate Injection immediately. Contact Safecor Health, LLC or your healthcare provider for further guidance. Notifications will primarily be sent via email.

Contact Information

For assistance, reach Safecor Health, LLC via email at their official website. Additional guidance may be obtained from healthcare providers.

Key Facts

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

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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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