The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0831-2021·Announced 2021-10-06

Aveeno Protect + Refresh Sunscreen Spray Recalled for cGMP Deviations

Johnson & Johnson Consumer, Inc. is recalling Aveeno Protect + Refresh sunscreen weightless spray SPF 60 nationwide due to cGMP (current good manufacturing practice) deviations.

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: This is an FDA Class II recall initiated voluntarily by the manufacturer due to cGMP deviations. No illnesses or injuries have been reported, and the hazard is manufacturing process-related rather than a known product contamination or defect with documented harm. Class II recalls with no reported illness and voluntary firm initiation typically warrant a Moderate severity rating.

Plain-English summary

Johnson & Johnson Consumer, Inc. is recalling Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60 (NET WT. 5.0 oz / 141 g aerosol cans, UPC 3 8137-119462 9) distributed nationwide in the United States.

The recall was initiated by the firm on July 14, 2021, due to cGMP deviations identified during manufacturing. The FDA classified this as a Class II recall on September 24, 2021. All lots within expiry are affected, and approximately 134,280 cans have been distributed.

Consumers who have purchased this product should stop using it. The FDA has not reported any illnesses or injuries associated with this recall. Consumers with questions should contact Johnson & Johnson Consumer, Inc. at the address listed on the package or through the FDA's drug recall website.

The recalled product

Product
Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 (OZ) (141 g) aerosol can, Distributed by: Johnson & Johnson Consumer Inc., Skillman, NJ 08558 UPC 3 8137-119462 9
Manufacturer
Johnson & Johnson Consumer, Inc.
Category
Drug — Sunscreen / Topical
Hazard
Affected units
134,280

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 →

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