FDA Drug recall D-0214-2026
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan… by Safecor Health, citing labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0214-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-10 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Safecor Health |
| Distribution | MA |
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
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Identifiers
| ndc | 67457-426-00 |
|---|---|
| ndc | 67457-426-12 |
| code_info | Lot 25381993 and 25391516, Exp 12/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0214-2026%22
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