Why it was recalled
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
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.
Lot numbers, UPCs & expiration codes
Lot 25381993 and 25391516, Exp 12/31/2026
Where it was sold
Distributed in Massachusetts
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0214-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 10, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 800 1mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0214-2026, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97977
- Address
- 317 New Boston St
- Code information
- Lot 25381993 and 25391516, Exp 12/31/2026
- Postal code
- 01801-6231
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0214-2026
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 800 1mL vials
- Reason for recall
- Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed in Massachusetts
- Recall initiation date
- Oct 10, 2025
- Initial firm notification
- Center classification date
- Dec 2, 2025