FDA recall D-0214-2026

Safecor Health, LLC · Class II · drug

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.

Reason for recall

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

Distribution

Distributed in Massachusetts

Key facts

Status: Ongoing
Initiation date: 2025-10-10
Report date: 2025-12-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0214-2026