The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0368-2025·Announced 2025-04-30

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units
14,189

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.

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 →

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