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Drug FDA Class II Ongoing Mislabeling

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 8001-03A

Safecor Health, LLC Published Dec 10, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Safecor Health, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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.

HALOPERIDOL LACTATE · 800 1mL vials

NDC: 67457-426, 67457-426-00, 67457-426-12
Lot codes: 25381993
Code info: Lot 25381993 and 25391516, Exp 12/31/2026

Affected areas

Massachusetts

Timeline

  1. Initiated
    Oct 10, 2025
  2. Published
    Dec 10, 2025
Recall number
D-0214-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.