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Class II · ModerateActive recall

Haloperidol Lactate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot 25381993 and 25391516, Exp 12/31/2026
Where it was soldDistributed in Massachusetts
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Institutional LLC
Brand nameHALOPERIDOL LACTATE
Generic nameHALOPERIDOL LACTATE
Active ingredient(s)HALOPERIDOL LACTATE
Distributed by / forMylan Institutional LLC, Morgantown, WV 26605
NDC67457-426-12
Show the full FDA record
Full product labelHaloperidol 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.
Recalling firmSafecor Health, LLC
DistributionDistributed in Massachusetts
Quantity800 1mL vials
Recall initiated2025-10-10
Report date2025-12-10
Recall completed—
Recall numberD-0214-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWoburn MA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.