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 i

FDA recall notice · announced December 10, 2025 · Safecor Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Distributed in Massachusetts
Lot/code information: Lot 25381993 and 25391516, Exp 12/31/2026
Quantity: 800 1mL vials
Status: Ongoing
Products in this recall event:
- 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 wi (D-0214-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.