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.
- Brand
- HALOPERIDOL LACTATE
- 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.
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