The Recall Desk
SevereFDA (Drugs)·D-0369-2025·Announced 2025-04-30

Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection vials nationwide because some media fill units showed bacterial contamination, indicating a lack of sterility assurance. The affected product is a 100mg/mL injectable antipsychotic medication.

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: This is an FDA Class II recall involving a sterile injectable drug with confirmed bacterial contamination in media fill units, which indicates a manufacturing control failure. Although no illnesses have been reported, the confirmed contamination and injectable route of administration create significant risk of serious patient harm if contaminated vials were used.

Plain-English summary

Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection, 100mg/mL, 5 × 1 mL single-dose vials (NDC 68001-581-48 and related package codes, lot A240482B with expiration date 08/31/2026) distributed nationwide. The recall was initiated because bacterial contamination was detected in some media fill units, meaning the sterility of affected vials cannot be assured.

Haloperidol Decanoate is an antipsychotic medication administered by intramuscular injection. Contaminated vials pose a potential risk of infection if administered to patients. The FDA has classified this as a Class II recall.

Patients currently using this product should contact their healthcare provider or pharmacist immediately. Do not use any vials from the recalled lot. Healthcare providers and pharmacies should quarantine and return affected inventory to the distributor. For more information, contact the recalling firm or the FDA.

The recalled product

Product
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Brand
HALOPERIDOL DECANOATE
Manufacturer
Amerisource Health Services LLC
Category
Drug — Injectable / Antipsychotic
Hazard

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.

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

Same manufacturer · Amerisource Health Services LLC

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Same hazard · bacterial contamination

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