Recalls / Class II
Class IID-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 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.
- Brand name
- Haloperidol Lactate
- Generic name
- Haloperidol Lactate
- Active ingredient
- Haloperidol Lactate
- Route
- Intramuscular
- NDC
- 67457-426
- FDA application
- ANDA078347
- Affected lot / code info
- Lot 25381993 and 25391516, Exp 12/31/2026
Why it was recalled
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Recalling firm
- Firm
- Safecor Health, LLC
- Manufacturer
- Mylan Institutional LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 317 New Boston St, Woburn, Massachusetts 01801-6231
Distribution
- Quantity
- 800 1mL vials
- Distribution pattern
- Distributed in Massachusetts
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-12-02
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0214-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.