Class II · Moderate risk
Haloperidol Lactate Injection
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Is Haloperidol recalled?
Yes — there is an active recall. 9 ongoing FDA recalls mention Haloperidol (18 total). Check the affected lots below.
Most common reason: Sterility / contamination (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Haloperidol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Haloperidol recalls on record
none so far in 2026; 18 on record, newest first
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 100mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol decanoate Injection 50mg/mL
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk
Haloperidol Decanoate Injection 100 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HALOPERIDOL TABLETS 20mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class II · Moderate risk
Haloperidol Oral Solution
Defective Container: Confirmed customer complaints of leaking bottles.
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
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