The Recall Desk
ModerateFDA (Drugs)·D-0214-2026·Announced 2025-12-10

Haloperidol injection vials recalled over incorrect RFID tag labels

Safecor Health is recalling 800 vials of Haloperidol Lactate Injection because incorrect RFID tag labels were applied to the product by the repackaging firm.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 under the minor labeling criterion: the record cites incorrect RFID tag serial numbers with no stated clinical consequence or reported harm.

Plain-English summary

Haloperidol Lactate Injection, 5 mg/mL, supplied as 25 x 1 mL single-dose vials for intramuscular use only, manufactured for Mylan Institutional LLC of Morgantown, West Virginia under NDC 67457-426-12, is being recalled. The vials carry a Safecor Health LLC KITCHECK RFID tag.

The reason given in the enforcement record is a labeling issue: incorrect RFID tag labels were applied to the product by the repackaging firm. The record identifies the incorrect serial numbers as KITCHECK 8001-03A3,00000000,003A-2560 and 8001-03A3,00000000,003A-2D3B.

The recall covers 800 1mL vials from lots 25381993 and 25391516, expiry 12/31/2026. Distribution was in Massachusetts. The FDA has classified the action as Class II.

The record describes an incorrect tag serial number rather than a defect in the medicine, and states no injuries. Facilities should follow Safecor Health's instructions.

The recalled product

Product
HALOPERIDOL LACTATE (HALOPERIDOL LACTATE)
Brand
HALOPERIDOL LACTATE

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 25381993 and 25391516
  • Exp 12/31/2026

Distribution

Distributed in 1 state: