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Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intram...

FDA Recall #D-0214-2026 — Class II — October 10, 2025

Recall #D-0214-2026 Date: October 10, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Reason for Recall

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

Recalling Firm

Safecor Health, LLC — Woburn, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

800 1mL vials

Distribution

Distributed in Massachusetts

Code Information

Lot 25381993 and 25391516, Exp 12/31/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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