Somerset Therapeutics recalls Haloperidol Decanoate 100mg/mL vials due to potential bacterial contamination. Affected vials have specific NDC codes and expiration dates. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics has recalled certain Haloperidol Decanoate Injection vials because they may contain bacterial contamination. This could lead to infections if used improperly. The recall affects specific product batches with known NDC codes and expiration dates.
The vials may have been contaminated during the manufacturing process, which could lead to bacterial growth. If the medication is injected, this contamination could cause infections or other health issues.
People who have been prescribed Haloperidol Decanoate Injection by a doctor and received the recalled vials. Those using the medication for mental health conditions are most at risk if the vials are contaminated.
Check for NDC codes 68001-581-41 (single vial) or 68001-581-48 (5 vial packs) with expiration dates of 08/2026. The vials are labeled with specific product codes like A240482A or A240482B.
Look for NDC codes 68001-581-41 or 68001-581-48 on the vial packaging with an expiration date of 08/2026.
The product may contain bacterial contamination during manufacturing, which could lead to infections if used.
Check the NDC codes and expiration dates on the vial packaging. If you have the recalled vials, contact Somerset Therapeutics for further instructions.
The recall is due to potential bacterial contamination, which could cause infections. However, the risk is considered low as the product is prescription-only and the contamination is not expected to cause immediate serious harm.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0357-2025 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0357-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
