FDA Drug Recalls

Recalls / Generics / Haloperidol Decanoate

Haloperidol Decanoate

12 FDA drug recalls involving generic “Haloperidol Decanoate.

DateClassProductFirm
2025-04-02Class IIHaloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset ThAmerisource Health Services LLC
2025-04-02Class IIHaloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset TherapeutAmerisource Health Services LLC
2025-04-02Class IIHaloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset ThAmerisource Health Services LLC
2025-03-21Class IIHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset TherapeuticSomerset Therapeutics Private Limited
2025-03-21Class IIHaloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset TherapeuticSomerset Therapeutics Private Limited
2025-03-21Class IIHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset TherapeuticsSomerset Therapeutics Private Limited
2025-03-21Class IIHaloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset TherapeuSomerset Therapeutics Private Limited
2024-04-24Class IIHaloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mSOMERSET THERAPEUTICS LLC
2016-04-07Class IIIHaloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, Fresenius Kabi USA, LLC
2015-02-18Class IIHaloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409Mylan Institutional LLC
2015-02-18Class IIHaloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-Mylan Institutional LLC
2014-04-14Class IIIHALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NFresenius Kabi USA LLC