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Regent - safety alert

Official notice

7 May 2025

MediumFDA

An official FDA notice concerns Regent. The notice reports a health risk requiring medical assessment. Do not use the product and follow the official notice. Published 2025-05-07. Lots: 24025N0C0, 24115N0C0, 24116N0C0, 24160N0C0, 24217N0C0 and 2 more. Recall numbers: D-0398-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

29,777

Recall number

D-0398-2025

Official notice

2025-05-07

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

24025N0C0, 24115N0C0, 24116N0C0, 24160N0C0, 24217N0C0, 24288N0C0, 24331N0C0

Event Ids

96695

Recall Numbers

D-0398-2025

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Regent. Contact: American Regent, Inc..

Source & status

Source

Tier

official

Category

HEALTH

Classification

Class II

App estimate

medium

Recall details

Recall number

D-0398-2025

Event id

96695

Units affected

29,777

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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