Haloperidol Lactate Injection recall
FDA recall D-0214-2026 · initiated Oct 10, 2025
Safecor Health, LLC recalled Haloperidol Lactate Injection in Oct 2025 — an FDA Class II recall (D-0214-2026) because Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 800 1mL vials
Details
- 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.
- Recalling company
- Safecor Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed in Massachusetts
- Initiated
- Oct 10, 2025
- FDA report date
- Dec 10, 2025
Frequently asked
- Was Haloperidol Lactate Injection recalled?
- Safecor Health, LLC recalled Haloperidol Lactate Injection in Oct 2025 — an FDA Class II recall (D-0214-2026) because Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Haloperidol Lactate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0214-2026 was: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
- Is a recalled Haloperidol Lactate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Haloperidol Lactate Injection are affected?
- Distributed: Distributed in Massachusetts. The recall covers these lots — Lot 25381993 and 25391516, Exp 12/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0214-2026.