Antipsychotic Injectable Drug Recalled Nationwide for Bacterial Contamination
Somerset Therapeutics' Haloperidol Decanoate injection is recalled nationwide because bacterial contamination was found during sterility testing. The medication is used to treat psychiatric conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable medication with confirmed bacterial contamination found during sterility testing. Although no illnesses or injuries have been reported in the source, the recall qualifies as High severity because it involves a risk-of-harm product (injectable medication) where contamination poses a potential serious infection risk, and injury has not yet been reported.
Plain-English summary
Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection 50mg/mL, 1mL single-dose vials manufactured for BluePoint Laboratories. The recall affects 4,956 vials nationwide. The recalled lot is identified by code A240467B with an expiration date of July 2026.
The FDA classified this as a Class II recall due to lack of assurance of sterility. During sterility testing (media fill testing), bacterial contamination was detected. Haloperidol Decanoate is an injectable antipsychotic medication used to treat psychiatric conditions. Contaminated injectable medication could potentially cause serious infection.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine if they have received a vial from this recalled lot. Do not use any vials from the recalled lot. Patients should not stop taking their prescribed medication without speaking to their healthcare provider, as abruptly stopping antipsychotic medications can be dangerous.
For more information, patients and healthcare providers can visit the FDA's drug recalls website or contact Somerset Therapeutics or BluePoint Laboratories.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Category
- Drug — Injectable Antipsychotic
- Hazard
- bacterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- A240467B
- exp. date 07/2026
UPCs (4)
- 0368001578592
- 0368001581417
- 0368001579599
- 0368001582414
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · HALOPERIDOL DECANOATE
- HighPrescription Haloperidol Decanoate Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2025-04-30
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FDA (Drugs) · 2025-04-30
- HighHaloperidol Decanoate injection recalled due to sterility assurance failure
FDA (Drugs) · 2025-04-16
- HighHaloperidol Decanoate injection recalled for sterility assurance failure
FDA (Drugs) · 2025-04-16
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