FDAClass IIDecember 10, 2025

Haloperidol Lactate Injection recall: Labeling Error

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…

Why was Haloperidol Lactate Injection recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 25381993 and 25391516, Exp 12/31/2026

Product
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…
Recalling firm
Safecor Health, LLC
Quantity
800 1mL vials
Distribution
Distributed in Massachusetts
Recall date
December 10, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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