FDA Recall D-0845-2021

Johnson & Johnson Consumer, Inc. · Skillman, NJ

Class I — life-threatening Ongoing 1765 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

Lot / code: 06320E26, exp 1/2023

Quantity: 387,648 cans

Reason for recall

Chemical Contamination: presence of benzene

Recall record

Recall number: D-0845-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide in US
Recall initiated: 2021-07-14
Classified by FDA Center: 2021-09-24
FDA published: 2021-10-06
Recalling firm: Johnson & Johnson Consumer, Inc.
Firm location: Skillman, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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