Injectable Drug Haloperidol Decanoate Recalled for Bacterial Contamination
Amerisource Health Services LLC recalled Haloperidol Decanoate injection nationwide due to lack of sterility assurance. Bacterial contamination was detected during quality testing of batch A240482B.
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 drug recall with bacterial contamination detected during sterility testing. No illnesses or injuries have been reported; the hazard is a potential risk of infection from non-sterile injections. This qualifies as High severity under the rubric's criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Haloperidol Decanoate Injection (100 mg/mL) in single-dose vials is being recalled. Affected product includes 143 units (5 vials each) with batch code A240482B and expiration date 08/31/2026, distributed nationwide in the USA.
The recall was initiated due to lack of assurance of sterility. Bacterial contamination was detected in some media fill test units. Media fill testing is part of quality assurance to verify manufacturing processes maintain proper sterility standards. The detected contamination indicates that distributed product may not meet required sterility standards for injectable medications.
Healthcare facilities, pharmacies, and individuals should not use product from the affected batch. Stop using the batch immediately and return or dispose of it according to pharmaceutical waste guidelines. Contact your pharmacy or healthcare provider if you have questions about medication you may have received.
Anyone who has received an injection from this batch should contact their healthcare provider to report the potential exposure and discuss whether any follow-up care is needed.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Injectable
- Hazard
- bacterial-contamination
- sterility-compromise
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)
- A240482B
- EXP 08/31/2026
UPCs (4)
- 0368001578592
- 0368001581417
- 0368001579599
- 0368001582414
Distribution
Distributed nationwide across the United States.
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