Haloperidol Decanoate Injection recalled over sterility concerns
- Recall date
- April 2, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Amerisource Health Services LLC recalls Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limit…
- Recall number
- D-0367-2025
- FDA classification
- Class II
- Brand / firm
- Amerisource Health Services LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
Get recall alerts
Free email alert whenever Amerisource Health Services LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Amerisource Health Services LLC