FDA Drug Recalls

Recalls / Class I

Class ID-0014-2022

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9

Affected lot / code info
Lot# TN00BU3, exp. date 05/31/2024

Why it was recalled

Chemical contamination; presence of benzene

Recalling firm

Firm
Beiersdorf Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
45 Danbury Rd, N/A, Wilton, Connecticut 06897-4405

Distribution

Quantity
143,376 cans
Distribution pattern
Nationwide in the US

Timeline

Recall initiated
2021-09-30
FDA classified
2021-10-15
Posted by FDA
2021-10-27
Terminated
2023-04-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0014-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.