Haloperidol Decanoate recalls

Haloperidol Decanoate products have been recalled 12 times, most recently on 30 Apr 2025. The recalling company is usually Somerset Therapeutics Private. The most common reason is sterility.

Total recalls12since 2014

Last 12 months0reported

Class I00% of total

Ongoing8latest 30 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 7 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 10 83%Class III 2 17%

Why haloperidol decanoate is recalled

Companies

Product types

Injectable & IV Drugs12100%

By year

2025758%
202418%
201618%
2015217%
201418%

Ongoing haloperidol decanoate recalls

8 active

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 50mg/mL* Single-Dose Vial recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL*, mL Single-Dose Vial recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide

All haloperidol decanoate recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 50mg/mL* Single-Dose Vial recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL*, mL Single-Dose Vial recalledHaloperidol Decanoate	Amerisource Health Services	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
16 Apr 2025Drug	CLASS II	Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate	Somerset Therapeutics Private	Sterility	Nationwide
29 May 2024Drug	CLASS II	Haloperidol decanoate Injection 50mg/mL recalledHaloperidol Decanoate	Somerset Therapeutics	Foreign Material	Nationwide
20 Apr 2016Drug	CLASS III	Haloperidol Decanoate Injection, 50 mg/mL vial recalledHaloperidol Decanoate	Fresenius Kabi USA	Potency & Assay	Nationwide
1 Apr 2015Drug	CLASS II	Haloperidol Decanoate Injection, 50 mg/mL recalledHaloperidol Decanoate	Mylan Institutional	Sterility	Nationwide
1 Apr 2015Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL recalledHaloperidol Decanoate	Mylan Institutional	Sterility	Nationwide
19 Nov 2014Drug	CLASS III	Haloperidol Decanoate Injection, 50 mg/mL vial recalledHaloperidol Decanoate	Fresenius Kabi USA	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.