FDA Recall D-0214-2026

Safecor Health, LLC · Woburn, MA

Class II Ongoing 216 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot 25381993 and 25391516, Exp 12/31/2026

Quantity: 800 1mL vials

Reason for recall

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Recall record

Recall number: D-0214-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Distributed in Massachusetts
Recall initiated: 2025-10-10
Classified by FDA Center: 2025-12-02
FDA published: 2025-12-10
Recalling firm: Safecor Health, LLC
Firm location: Woburn, MA

Drug identification

Brand name(s): HALOPERIDOL LACTATE
Generic name(s): HALOPERIDOL LACTATE
Manufacturer(s): Mylan Institutional LLC
NDC(s): 67457-426
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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