Haloperidol Decanoate recalls
The FDA has published 15 recalls involving Haloperidol Decanoate since 2014. The latest was reported on 30 Apr 2025. Most were for sterility. Somerset Therapeutics Private has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls15since 2014
Last 12 months0reported
Class I00% of total
Ongoing8latest 30 Apr 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 13 87%Class III 2 13%
Why haloperidol decanoate is recalled
Companies
By year
Ongoing haloperidol decanoate recalls
8 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Haloperidol Decanoate Injection, 50mg/mL* Single-Dose Vial recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100 mg/mL*, mL Single-Dose Vial recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100 mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
All haloperidol decanoate recalls, newest first
15 totalShould you stop taking Haloperidol Decanoate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.