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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Injectable
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:
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