Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0838-2021·Announced 2021-10-06

Neutrogena Ultra Sheer Body Mist Sunscreen Recall for cGMP Deviations

Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 70 (5.0 oz aerosol cans) due to cGMP manufacturing deviations. The product was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall, and the source text explicitly states no illnesses or injuries have been reported. The hazard is a cGMP deviation, which represents a manufacturing/quality control issue rather than an acute safety threat. Per the rubric, FDA Class II recalls without reported harm or high-risk pathogens fall in the Moderate range.

Plain-English summary

Johnson & Johnson Consumer, Inc. is voluntarily recalling approximately 2,724,480 cans of Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70 (Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%), NET WT. 5.0 OZ (141 g) aerosol can (UPC 0 86800 10040 9). The recall was initiated by the firm on July 14, 2021, and the FDA classified it as a Class II recall on September 24, 2021.

The product is being recalled due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. All lots within the product's expiration date are affected.

The product was distributed nationwide in the United States. Consumers who have purchased this product should stop using it and may contact Johnson & Johnson Consumer, Inc. for further information regarding the recall.

The recalled product

Product: Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9
Manufacturer: Johnson & Johnson Consumer, Inc.
Category: Drug — Sunscreen / Topical Drug
Hazard: cgmp-deviation
manufacturing-defect
Affected units: 2,724,480

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Johnson & Johnson Consumer, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · Johnson & Johnson Consumer, Inc.

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Same hazard · cgmp deviation