Haloperidol Decanoate Injection Recalled for Lack of Sterility Assurance
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 affected product was distributed nationwide.
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 source explicitly identifies this as an FDA Class II recall. Per the rubric, Class II recalls with potential for serious health consequences (sterility assurance failure in an injectable drug) meet the Severe threshold. Although no hospitalization or illness reports are mentioned, the hazard of bacterial contamination in a parenteral product carries inherent risk of serious infection.
Plain-English summary
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection, 100 mg/mL, 1 x 1 mL Single-Dose Vial (NDC 68001-581-41), with lot code A240482A and expiration date 08/31/2026. A total of 14,189 vials have been distributed nationwide. The recall is due to lack of assurance of sterility, with bacterial contamination detected in some media fill units.
Haloperidol Decanoate Injection is a prescription antipsychotic medication administered by intramuscular injection. The product was manufactured by Somerset Therapeutics Limited in India and distributed for BluePoint Laboratories.
The FDA classified this as a Class II recall. Patients and healthcare providers should contact Amerisource Health Services LLC or the FDA with questions. Any unused product from the affected lot should not be used and should be reported to the recalling firm.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Injectable Antipsychotic
- Hazard
- bacterial-contamination
- sterility-assurance
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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