Prescription Haloperidol Decanoate Injection Recalled Due to Sterility Assurance Failure
Amerisource Health Services LLC is recalling 2,110 vials of Haloperidol Decanoate injection because bacterial contamination was detected in manufacturing. The vials were 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: FDA Class II recall of a sterile injectable drug with bacterial contamination detected during manufacturing quality testing. No illnesses or injuries reported, but contamination poses inherent risk of infection if product was administered.
Plain-English summary
Haloperidol Decanoate is a prescription injectable antipsychotic medication administered intramuscularly. This recall involves 2,110 single-dose vials of Haloperidol Decanoate (50 mg/mL, 1 mL) with lot number A240467B and an expiration date of July 31, 2026, manufactured by Somerset Therapeutics Limited and distributed by Amerisource Health Services LLC.
Amerisource Health Services LLC initiated the recall after bacterial contamination was detected in media fill units, indicating a lack of assurance of sterility during the manufacturing process. Media fill testing is a procedure used to verify that sterilization processes are effective. The FDA classified this as a Class II recall.
The affected vials were distributed nationwide in the United States.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Injectable Antipsychotic
- 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)
- A240467B
- EXP 07/31/2026
UPCs (4)
- 0368001578592
- 0368001581417
- 0368001579599
- 0368001582414
Distribution
Distributed nationwide across the United States.
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