The Recall Desk
ModerateFDA (Drugs)·D-0001-2016·Announced 2015-10-07

Guthy-Renker Recalls Rodan & Fields Proactiv Foundation for Subpotent Salicylic Acid

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

What this means for you

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 the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. A score of 2 is assigned to reflect the subpotent nature of the drug, which is a minor labeling or potency error rather than a high-risk contamination.

Plain-English summary

Guthy-Renker LLC is recalling specific lots of Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, FAIR. The product is an over-the-counter salicylic acid acne treatment manufactured for Guthy-Renker LLC in Palm Desert, California.

The recall was initiated because the salicylic acid in the affected products is subpotent, meaning it does not contain the full amount of the active ingredient required. The affected products include 9,960 compacts with lot numbers N0362A, N0363A, N1264A, and N1265A. These products were distributed nationwide in the United States, including Puerto Rico and Guam, as well as in Canada.

Consumers who have these specific lot numbers should stop using the product and contact Guthy-Renker LLC for a refund or replacement. The agency has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.

The recalled product

Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 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
9,960

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 (7)

  • Lot #: N0362A
  • Expiry: 12/12
  • Lot #: N0363A
  • Lot #: N1264A
  • Expiry: 09/13
  • Lot #: N1265A
  • Expiry: 09/13.

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 →

Related recalls

Same manufacturer · Guthy-Renker LLC

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Same hazard · subpotent drug

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