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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- HALOPERIDOL LACTATE, Mylan Institutional LLC
- Product type
- Haloperidol Lactate Injection
- Model numbers
- Lot 25381993 and 25391516, Exp 12/31/2026
- UPC codes
- 67457-426, 67457-426-00, 67457-426-12
- Sold at
- Multiple Retailers
- Where affected
- MA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the lot number on your Haloperidol Lactate vials.
- Ensure it matches Lot 25381993 or Lot 25391516.
- 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.
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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.
Key Facts
- Recall date: October 10, 2025
- Distributed in Massachusetts
- Incorrect RFID labels applied
- Stop use immediately
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Safety Guide
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