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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Haloperidol Lactate Injection Recalled for Incorrect RFID Tag Labels

Agency Publication Date: December 2, 2025
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Summary

Safecor Health, LLC is recalling 800 vials of Haloperidol Lactate Injection (5 mg/mL), a medication used to treat certain mental and emotional disorders. The recall was initiated because the repackaging firm applied incorrect RFID tag labels to the vials, which contain incorrect serial numbers. This labeling error could lead to confusion or errors in hospital inventory systems that rely on these tags for tracking medication. No injuries or patient safety incidents have been reported to date regarding this specific labeling defect.

Risk

The incorrect serial numbers on the RFID tags could cause hospital automated systems to misidentify the medication or its batch information, potentially leading to inventory tracking errors in clinical settings.

What You Should Do

  1. Check your supply for Haloperidol Lactate Injection, 5 mg/mL (25 x 1 mL single-dose vials) with NDC 67457-426-12.
  2. Verify the lot numbers and expiration dates: Look for lot 25381993 and lot 25391516 with an expiration date of 12/31/2026.
  3. Identify if the RFID tags match the following incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560 or 8001-03A3,00000000,003A-2D3B.
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Haloperidol Lactate Injection (5 mg/mL)
Variants: 5 mg/mL, 1 mL Single-Dose Vials, Sterile, Intramuscular Use Only
Serial Numbers:
8001-03A3,00000000,003A-2560
8001-03A3,00000000,003A-2D3B
Lot Numbers:
25381993 (Exp 12/31/2026)
25391516 (Exp 12/31/2026)
NDC:
67457-426-12

Manufactured for: Mylan Institutional LLC. Repackaged by Safecor Health LLC with KitCheck RFID tags.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97977
Status: Active
Manufacturer: Safecor Health, LLC
Sold By: Mylan Institutional LLC; Safecor Health LLC; Institutional distributors
Manufactured In: United States
Units Affected: 800 1mL vials
Distributed To: Massachusetts

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.