Haloperidol Decanoate injection recalled due to sterility assurance failure
Amerisource Health Services is recalling Haloperidol Decanoate injection due to lack of sterility assurance. Bacterial contamination was detected in validation testing during manufacturing quality control.
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 for bacterial contamination in a sterile injectable. Per the rubric, high-risk pathogens without reported illness score High (3).
Plain-English summary
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection, 100 mg/mL, administered by intramuscular injection. The affected lot is A240482A, expiration date 08/31/2026. Approximately 14,189 vials are involved, distributed nationwide in the USA.
The recall was initiated due to lack of assurance of sterility. Bacterial contamination was detected during manufacturing quality control testing in some media fill validation units. Media fill testing is a method used to validate the sterility assurance of a manufacturing process. Detection of contamination in these tests indicates a potential break in the sterility assurance process for the affected lot.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Antipsychotic Injectable
- 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)
- A240482A
- EXP 08/31/2026
UPCs (4)
- 0368001578592
- 0368001581417
- 0368001579599
- 0368001582414
Distribution
Distributed nationwide across the United States.
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