Amerisource Health Services recalls Haloperidol Decanoate Injection vials due to bacterial contamination detected in some media fill units. This poses a risk of infection if injected.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services is recalling Haloperidol Decanoate Injection vials because bacterial contamination was found in some units. Using these vials could lead to infection if injected.
The injection vials were found to have bacterial contamination in some media fill units. This contamination could cause infection if the vial is used for injection.
Prescription patients using the recalled Haloperidol Decanoate Injection vials. Patients who have already received the injection are at higher risk of infection.
The product is Haloperidol Decanoate Injection, 100mg/mL, 5 x 1 mL Single-Dose Vials, Rx Only. It was manufactured by Somerset Therapeutics in India and distributed by Amerisource Health Services.
Verify the expiration date on the vial, which is 08/31/2026.
The recall states bacterial contamination was detected in some units, so it is not safe to use without checking the recall status.
Look for the product name: Haloperidol Decanoate Injection, 100mg/mL, 5 x 1 mL Single-Dose Vials, Rx Only, manufactured by Somerset Therapeutics.
The recall does not specify a remedy, so contact your healthcare provider 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-0369-2025 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0369-2025 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.
