Haloperidol Decanoate recalls

Haloperidol Decanoate products have been recalled 9 times, most recently on 30 Apr 2025. The recalling company is usually Amerisource Health Services. The most common reason is sterility.

Total recalls9since 2014

Last 12 months0reported

Class I00% of total

Ongoing5latest 30 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 5 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 7 78%Class III 2 22%

Why haloperidol decanoate is recalled

Sterility778%
Potency & Assay222%

Companies

Product types

Injectable & IV Drugs9100%

By year

2025556%
2016111%
2015222%
2014111%

Ongoing haloperidol decanoate recalls

5 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

All haloperidol decanoate recalls, newest first

9 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
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.