HALOPERIDOL DECANOATE

Generic: HALOPERIDOL DECANOATE

Fresenius Kabi USAManufacturer
INTRAMUSCULARRoute
HALOPERIDOL DECANOATEActive Substance
1997-12-19Original Approval

HALOPERIDOL DECANOATE is FDA application ANDA074893, sponsored by FRESENIUS KABI USA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-03-21
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class II2024-04-24
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injecti

Class II2015-02-18
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packa

Lack of Assurance of Sterility; due to leaking vials

Class II2025-04-02
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class II2015-02-18
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packag

Lack of Assurance of Sterility; due to leaking vials

Class III2014-04-14
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-

Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol

Class II2025-04-02
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class II2025-04-02
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limite

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class II2025-03-21
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC,

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class II2025-03-21
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So

Lack of Assurance of Sterility: Media fill with bacterial contamination

Top Reported Reactions

1
WEIGHT INCREASED
239 reports
2
DRUG INEFFECTIVE
167 reports
3
EXTRAPYRAMIDAL DISORDER
145 reports
4
OFF LABEL USE
131 reports
5
AKATHISIA
127 reports
6
DRUG INTERACTION
115 reports
7
SUICIDE ATTEMPT
107 reports
8
LEUKOPENIA
97 reports
9
TOXICITY TO VARIOUS AGENTS
97 reports
10
NEUROLEPTIC MALIGNANT SYNDROME
95 reports