The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0005-2016·Announced 2015-10-07

Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation

Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution compact foundation because the salicylic acid ingredient is subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard is a subpotent ingredient, which is a minor labeling/potency error rather than a direct safety risk like contamination or injury.

Plain-English summary

Guthy-Renker LLC is recalling 2,537 compacts of Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. The product is an over-the-counter medication manufactured for Guthy-Renker LLC in Palm Desert, CA.

The recall is being conducted because the salicylic acid in the product is subpotent, meaning it contains less than the labeled amount of the active ingredient. The affected lots are N0343A and N0344A, both with an expiry date of 12/12.

The product was distributed nationwide in the United States, including Puerto Rico and Guam, as well as in Canada. Consumers should stop using the product and contact Guthy-Renker LLC for a refund or further instructions.

The recalled product

Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Manufacturer
Guthy-Renker LLC
Category
Drug — Topical Acne Treatment
Hazard
Affected units
2,537

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 (4)

  • Lot #: N0343A
  • Expiry: 12/12
  • Lot #: N0344A
  • Expiry: 12/12.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Guthy-Renker LLC 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 5 products in this recall →

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