Haloperidol Decanoate Injection Recalled Due to Bacterial Contamination Risk
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to bacterial contamination detected during sterility validation testing. The contamination was found in media fill testing affecting 240 vials distributed nationwide.
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 for bacterial contamination in a high-risk injectable product. The contamination was detected during manufacturing validation (media fill testing) rather than in distributed product. Per the rubric, high-risk pathogen concerns without reported illness in risk-of-harm products warrant a High severity score.
Plain-English summary
Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL single-dose vials) after bacterial contamination was detected during sterility validation testing. The contamination was identified in media fill testing, which is part of the manufacturing process to verify sterility assurance.
The recall affects 240 vials with batch code A240482D and an expiration date of 08/2026. The product was distributed nationwide in the United States. Haloperidol Decanoate is a prescription medication administered by intramuscular injection.
Patients and healthcare providers should not use affected vials. Those with questions should contact Somerset Therapeutics or the FDA. Healthcare facilities should quarantine affected inventory and work with Somerset Therapeutics to confirm the status of any dispensed vials.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Category
- Drug — Injectable
- Hazard
- bacterial-contamination
- sterility-failure
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)
- A240482D
- exp. date 08/2026
UPCs (5)
- 0370069382011
- 0370069383018
- 0370069031018
- 0370069030011
- 0370069384015
Distribution
Distributed nationwide across the United States.
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