RECALL DATABASE

Haloperidol Lactate Injection Recall: Safecor Health Lot 25381993

Announced 2026-05-27 · FDA

FDA recall for Haloperidol Lactate Injection 5 mg/mL, 25 x 1 mL single-dose vials, due to labeling: incorrect RFID tag labels applied to product by repackaging firm. Lot 25381993 and 25391516 (Exp 12/31/2026) distributed in Massachusetts are affected.

BrandSafecor Health, LLC
ProductHaloperidol 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.
ReasonLabeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Severitymoderate
Units affected149
DistributionDistributed in Massachusetts
AgencyFDA
Recall / campaign no.Lot 25381993 and 25391516, Exp 12/31/2026

WHAT YOU SHOULD DO

  1. Do not use recalled Haloperidol Lactate Injection from Lot 25381993.
  2. Consult your healthcare provider or pharmacy for a replacement.
  3. Return or dispose of recalled vials per facility instructions.
  4. Contact FDA or the distributor with questions.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.