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Use caution Drug recall · FDA · Published October 10, 2025

Safecor Recalls Haloperidol Lactate Vials Due to Labeling Errors

Safecor Health recalls specific lots of Haloperidol Lactate Injection due to incorrect RFID tag labels. Check your vial serial numbers for potential issues.

🇺🇸 FDA recall #D-0214-2026DrugSafecor Health ›
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Contact the company

Recalling firmSafecor Health, LLC317 New Boston St · Woburn, MA 01801-6231
✎ GovInfoNow plain-language explainer

What happened, in plain English

Safecor Health, LLC is recalling Haloperidol Lactate Injection, 5 mg/mL, in 1 mL single-dose vials because the repackaging firm applied incorrect RFID tag labels with wrong serial numbers. The affected products are distributed in Massachusetts and expire on December 31, 2026. No remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/31718-safecor-recalls-haloperidol-lactate-vials-due-to-labeling-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/31718-safecor-recalls-haloperidol-lactate-vials-due-to-labeling-errors · Updated October 9, 2026 · FDA enforcement record: FDA #D-0214-2026

Cite this page

“Safecor Recalls Haloperidol Lactate Vials Due to Labeling Errors.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31718-safecor-recalls-haloperidol-lactate-vials-due-to-labeling-errors. Based on FDA recall #D-0214-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0214-2026%22&limit=1).

Why it’s dangerous

The incorrect RFID tag labels may lead to confusion or errors in identifying the specific product lot and serial number during handling or administration. This could potentially impact traceability and inventory management, though the record does not specify direct patient injury risks from the drug itself.

Who’s affected

Healthcare providers and patients in Massachusetts who have received Haloperidol Lactate Injection vials manufactured for Mylan Institutional LLC. The risk is primarily related to medication identification errors due to labeling issues.

How to tell if you have this one

Look for Haloperidol Lactate Injection, 5 mg/mL, in 25 x 1 mL single-dose vials with Safecor Health LLC KITCHECK RFID Tag. Check for incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B. Verify lot numbers 25381993 and 25391516 with expiration date 12/31/2026.

  • Brand
    Safecor Health
  • Category
    Drug

Where it went and when

Where it was distributed

Distributed in Massachusetts.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distributed in Massachusetts” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Massachusetts.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Oct 10, 202512. FDA classified it Class II: Dec 2, 202523. Published in FDA’s Enforcement Report: Dec 10, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0214-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0214-2026 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA