Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials
Recalled by Safecor Health, LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Safecor Health, LLC has recalled Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 10, 2025 and was initiated on October 10, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, with approximately 800 1mL vials affected. The company behind the recall is Safecor Health, LLC, based in Woburn, MA. The FDA describes the product as: “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 incor…”
Why was Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials recalled?
According to the FDA, the stated reason for the recall is: “Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.”
What should you do?
If you think you may have bought Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, compare it against the product description and identifying codes (Lot 25381993 and 25391516, Exp 12/31/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Safecor Health, LLC or your local health authority.
About this recall
This recall was distributed in MA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- December 10, 2025
- Recall started
- October 10, 2025
- Distributed in
- MA
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials recalled?+
According to the FDA: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0214-2026. Information last synced from the FDA on July 6, 2026.