The Recall Desk
ModerateFDA (Drugs)·D-0420-2021·Announced 2021-06-02

Cardinal Health Recalls Vraylar Capsules Due to Temperature Excursions

Cardinal Health is recalling 759 bottles of Vraylar (cariprazine) capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the probability of serious adverse health consequences is remote. The hazard involves storage conditions (temperature excursions) rather than a direct contamination or structural defect with immediate high-risk injury potential.

Plain-English summary

Cardinal Health Inc. is recalling 759 bottles of Vraylar (cariprazine) capsules in all pack sizes, styles, and strengths. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The product is distributed by Actavis Pharma, Inc., located in Parsippany, New Jersey.

The affected product, identified by code W04494, was distributed in Florida, Georgia, and South Carolina. Vraylar is a prescription-only medication. The source text does not specify the exact date of the recall or the specific strengths affected beyond stating "all pack sizes, styles and strengths."

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
759

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • W04494

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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