Haloperidol Decanoate Injection Recalled Due to Sterility Concerns
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The drug is used for intramuscular injection to treat psychiatric conditions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, and bacterial contamination in an injectable drug poses a serious risk of infection if contaminated units are administered, meeting the threshold for Severe (Class II with serious health risk).
Plain-English summary
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection, 50 mg/mL, in 1 mL single-dose vials, manufactured by Somerset Therapeutics Limited and distributed nationwide in the USA. A total of 2,110 vials with lot number A240467B and expiration date July 31, 2026 are affected.
The reason for the recall is lack of assurance of sterility. Bacterial contamination was detected in some media fill units during testing.
Haloperidol Decanoate Injection is a prescription medication administered by intramuscular injection. The affected product is sold under NDC 68001-580-41 and related package numbers.
Patients who have received this medication should contact their healthcare provider. Healthcare providers and patients should not use the recalled vials and should return them to their supplier or pharmacy.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Amerisource Health Services LLC
- Affected units
- 2,110
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.
Part of a larger recall action
This product is one of 3 recalled by Amerisource Health Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · HALOPERIDOL DECANOATE
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- SevereHaloperidol Decanoate Injection Recalled for Sterility Assurance Failure
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- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
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