Somerset Therapeutics recalls Haloperidol Decanoate 50mg/mL vials due to potential bacterial contamination. This injection risks infection if used. Contact the manufacturer for details.
Lack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics is recalling Haloperidol Decanoate Injection vials because they may contain bacteria. Using these vials could lead to infections, so affected users should stop using them immediately.
The vials may have been contaminated with bacteria during manufacturing, which could cause infections if injected. This is a serious risk because the product is used for medical treatment.
People with prescriptions for Haloperidol Decanoate Injection 50mg/mL, 1mL vials from Somerset Therapeutics Limited in India. Those using the product without medical supervision are at highest risk.
Check for vials labeled 'Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only' with NDC code 68001-580-41. The vials were manufactured by Somerset Therapeutics Limited in India and expire by July 2026.
Immediately discard the vial if you have it, as it may contain bacteria that could cause infection.
No, the vials may contain bacteria and could cause infection if used. Do not use these vials.
Look for vials labeled 'Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only' with NDC code 68001-580-41 manufactured by Somerset Therapeutics Limited in India.
Discard the vial immediately and contact Somerset Therapeutics for further instructions.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0356-2025 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0356-2025 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.
