Somerset Therapeutics recalls Haloperidol Decanoate 50mg/mL vials due to potential bacterial contamination. This injection, used for psychiatric conditions, may cause serious infection if contaminated. Affected vials have specific NDC numbers and expiration dates.
Lack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics is recalling Haloperidol Decanoate Injection vials because they may contain bacterial contamination. Using these vials could lead to serious infections, especially in medical settings where injections are administered.
The vials may have been contaminated during the manufacturing process, leading to bacterial growth. If injected, this could cause serious infections, including sepsis, which is life-threatening.
Patients prescribed Haloperidol Decanoate injections by a doctor are affected. Healthcare providers using these vials for medical treatment are at highest risk due to potential contamination.
Check for vials labeled 'Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only'. The NDC numbers are 70069-381-01 (single vial) or 70069-381-10 (10-pack). The expiration date is 07/2026.
Discard all affected vials immediately to prevent potential bacterial contamination and infection.
The vials may contain bacterial contamination during manufacturing, which could lead to serious infections if injected.
NDC 70069-381-01 (single vial) and NDC 70069-381-10 (10-pack) are affected.
Look for vials labeled 'Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only' with the specific NDC numbers and expiration date of 07/2026.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0355-2025 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0355-2025 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.
