Amerisource Health Services recalls Haloperidol Decanoate Injection due to bacterial contamination in some units. This injectable medication poses a risk of infection if used.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services is recalling Haloperidol Decanoate Injection vials that may contain bacterial contamination. Using these vials could lead to infection, especially since they are prescription-only medications.
The injection vials may have bacterial contamination due to issues during the manufacturing process. This contamination could cause infections if the medication is administered.
Prescription patients using Haloperidol Decanoate Injection for mental health conditions. Those with medical conditions requiring this medication are most at risk.
Check for the product name 'Haloperidol Decanoate Injection, 100 mg/mL, 1 x 1 mL Single-Dose Vial' with NDC 68001-581-41. The vials were manufactured by Somerset Therapeutics in India and distributed by Amerisource Health Services.
Verify the product label includes NDC 68001-581-41 and was manufactured by Somerset Therapeutics.
The recall indicates bacterial contamination was detected in some units, so it is not safe to use without checking the recall status.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
Check the product label for NDC 68001-581-41 and manufacturer details from Somerset Therapeutics.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0368-2025 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0368-2025 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.
