Haloperidol Lactate Injection 5 mg/mL Recall: Labeling Error
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Haloperidol Lactate Injection 5 mg/mL recalled?
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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.
Which lot codes, UPCs or models are affected?
Lot 25381993 and 25391516, Exp 12/31/2026
- Agency record number
- D-0214-2026
- Product
- Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…
- Recalling firm
- Safecor Health, LLC
- Quantity
- 800 1mL vials
- Distribution
- Distributed in Massachusetts
- Recall started
- October 10, 2025
- Report date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)