October 2025 FDA Recall Haloperidol Lactate by Safecor Health, Llc
D-0214-2026 - Labeling
This Class II drug recall was voluntarily initiated by Safecor Health, Llc on October 10, 2025 for the product Haloperidol Lactate. The FDA reported the reason for recall as labeling. The product was distributed in Distributed in Massachusetts and the recall is currently ongoing.
Recall Number: D-0214-2026
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
10-10-2025
12-10-2025
800 1mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed in Massachusetts
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# Lot 25381993 and 25391516, Exp 12/31/2026
