Class IIOngoing

Haloperidol Lactate Injection recall

FDA recall D-0214-2026 · initiated Oct 10, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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.
Recalling company: Safecor Health, LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed in Massachusetts
Initiated: Oct 10, 2025
FDA report date: Dec 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0214-2026 ↗

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