FDA Drugs recall ·
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials… recall
- Recall number
- D-0214-2026
- Date
- (initiated October 10, 2025)
- Company / brand
- Safecor Health, LLC
317 New Boston St, Woburn, MA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 800 1mL vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 25381993 and 25391516, Exp 12/31/2026
Distribution
Distributed in Massachusetts
States: Massachusetts
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0214-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.