Somerset Therapeutics recalls 100 mg/mL Haloperidol Decanoate Injection vials due to potential bacterial contamination. This could cause infection if used.
Lack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics is recalling certain Haloperidol Decanoate Injection vials because they may contain bacterial contamination. Using these vials could lead to infection.
The vials may have been contaminated during manufacturing, which could introduce bacteria into the injection. If injected, this could cause infection or other health issues.
Prescription patients using the recalled vials are affected. Healthcare providers who dispense these medications are at higher risk.
Check for vials labeled 'Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only' with NDC 70069-383-10. They were manufactured by Somerset Therapeutics in New Jersey.
Look for the NDC code 70069-383-10 on the vial label.
The recall states there is a risk of bacterial contamination, so it is not safe to use.
Check for vials labeled 'Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only' with NDC 70069-383-10.
The recall does not specify a remedy, so contact Somerset Therapeutics for guidance.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0358-2025 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0358-2025 from Somerset Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
