Reported Dec 10, 2025 · Ongoing
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only,…
Safecor Health, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Safecor Health, LLC · 317 New Boston St · Woburn, MA · 01801-6231
Is this the product you have?
- Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only
- Manufactured forMylan Institutional LLC, Morgantown, WV 26605
- NDC67457-426-12 with Safecor Health LLC KITCHECK RFID Tag
- attached with incorrect serial numbers
KITCHECK 8001-03A300000000003A-2560and 8001-03A300000000003A-2D3B
- Lot codes and dates
Lot 25381993 and 25391516Exp 12/31/2026
- Amount recalled
- 800 1mL vials
Where it was sold
Why it was recalled
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
This product could cause temporary or reversible health problems — stop using it.
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