FDAApril 2, 2025drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

What to do

FDA enforcement status: Ongoing

Brands named

amerisource health servicesamerisourceamerisource health

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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