NDC 50458-309

Risperdal Consta 12.5 mg per 2 mL kit

On the label: Janssen Pharmaceuticals, Inc..

United States: 1Switzerland: 1Ireland: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Alkermes, IncWilmington, OH, United StatesMakes it Problems found, fixed voluntarilyOct 19, 2023 · 10 inspections
Cilag AGSchaffhausen, SwitzerlandMakes it and packages it No problems foundNov 21, 2025 · 8 inspections
Janssen Pharmaceutical Sciences Unlimited CompanyCo Cork, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 27, 2023 · 5 inspections
AndersonBrecon Inc.Rockford, IL, United StatesPackages it No problems foundAug 19, 2026 · 11 inspections

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Risperidone: every company that makes it
Form
kit
Strength
12.5 mg per 2 mL
Approval
NDA NDA021346
On the market since
Oct 29, 2003
Package NDCs
50458-309-01 50458-309-11
Official label
DailyMed (National Library of Medicine), updated Nov 5, 2025

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