Antipsychotic Injection Recalled

Somerset Therapeutics is recalling 2 lots of haloperidol decanoate injection due to the presence of a foreign substance. According to the May 29, 2024, US Food and Drug Administration (FDA) Enforcement Report, the oil-based product may contain trace amounts of water for injection.

The recall affects the following products, which were manufactured in India for Somerset Therapeutics, Hollywood, Florida, and distributed throughout the United States:

• haloperidol decanoate injection 50 mg/mL, 1-mL single-dose vials (NDC 70069-381-01), from lot A230412A (Exp. 7/25); and 
• haloperidol decanoate injection 50 mg/mL, 10 1-mL single-dose vials (NDC 70069-381-10), from lot A230412B (Exp. 7/25).

Somerset Therapeutics voluntarily initiated the recall on April 24, 2024. On May 21, 2024, the FDA designated it Class II, communicating that use of the injection may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Haloperidol decanoate injection is a prescription antipsychotic used to treat patients with schizophrenia.