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
- Hazard
- bacterial-contamination
- lack-of-sterility
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.
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