FDA Drug Recalls

Recalls / Class II

Class IID-0837-2021

Product

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ, 08858,

Affected lot / code info
All lots within expiry.

Why it was recalled

cGMP Deviations

Recalling firm

Firm
Johnson & Johnson Consumer, Inc.
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
199 Grandview Rd, N/A, Skillman, New Jersey 08558-1311

Distribution

Quantity
a) 5oz-1,282,488; b) 8oz-475,476 cans
Distribution pattern
Nationwide in US

Timeline

Recall initiated
2021-07-14
FDA classified
2021-09-24
Posted by FDA
2021-10-06
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0837-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.