Haloperidol Decanoate injection recalled for sterility assurance failure
Somerset Therapeutics recalls 23,960 vials of Haloperidol Decanoate Injection due to bacterial contamination identified in manufacturing process validation testing, indicating potential sterility compromise.
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: FDA Class II recall with actual bacterial contamination identified in sterilization assurance testing of an injectable medication. No illnesses, hospitalizations, or deaths have been reported. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Somerset Therapeutics is recalling Haloperidol Decanoate Injection 100 mg/mL, 1 mL single-dose vials distributed nationwide. The affected product lots are A240482A and A240482B, both expiring August 2026. A total of 23,960 vials are subject to recall, with NDCs 68001-581-41 and 68001-581-48.
Bacterial contamination was identified during media fill testing, a manufacturing validation process designed to verify the sterilization assurance process. This finding indicates a potential failure in the manufacturing process that could compromise the sterility of the product.
Healthcare providers and patients should not use the recalled vials. Patients currently taking Haloperidol Decanoate from other sources should continue their treatment as prescribed. Anyone who may have received the recalled product should contact their healthcare provider.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Category
- Drug
- 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 (5)
- NDC 68001-581-41
- A240482A
- exp. date 08/2026
- NDC 68001-581-48
- A240482B
UPCs (4)
- 0368001578592
- 0368001581417
- 0368001579599
- 0368001582414
Distribution
Distributed nationwide across the United States.
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