Recall
FDAHealthOctober 10, 2025

Safecor Health, LLC — 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 2660

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

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
October 10, 2025

Distributed in Massachusetts

What's affected?

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.
Lot code
25381993

Additional details

Lot 25381993 and 25391516, Exp 12/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 800 1mL vials.

View original FDA notice →

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