Amerisource Health Services recalls Haloperidol Decanoate Injection due to bacterial contamination detected 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 in medical settings where sterile injections are critical.
The injection vials may have bacterial contamination due to issues during the manufacturing process. This contamination could cause infections if the medication is administered into the body.
Patients prescribed this injectable medication by a healthcare provider are affected. Those using the product without medical supervision are not at risk.
The product is a Haloperidol Decanoate Injection, 50mg/mL, 1 mL single-dose vial, manufactured by Somerset Therapeutics in India. It was sold with NDC 68001-580-41 and expires 07/31/2026.
Verify the product label includes NDC 68001-580-41 and expiration date 07/31/2026.
The recall indicates bacterial contamination was detected in some units, so it is not safe to use without checking the recall status.
The recall record does not specify a replacement process or remedy.
The recall record does not provide contact information for affected individuals.
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0367-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0367-2025 from Amerisource Health Services. 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.
