FDA Drug Recalls

Recalls / Class I

Class ID-0011-2022

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 Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

Affected lot / code info
Lot# TN00854, exp. date 01/31/2023 TN00855, exp. date 01/31/2023 TN00CJV, exp. date 06/30/2023

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
167,808 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-0011-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.