HALOPERIDOL DECANOATE

Generic: HALOPERIDOL DECANOATE

Mylan Institutional LLCManufacturer

INTRAMUSCULARRoute

HALOPERIDOL DECANOATEActive Substance

2000-02-28Original Approval

HALOPERIDOL DECANOATE is FDA application ANDA075440, sponsored by MYLAN LABS LTD. 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 II2025-10-10

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manu

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

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 II2021-03-15

HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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

HALOPERIDOL DECANOATE

Recalls

Top Reported Reactions