The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0003-2016·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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor issues.

Plain-English summary

Guthy-Renker LLC is recalling 5,025 compacts of Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. The product is an over-the-counter medication manufactured for Guthy-Renker LLC in Palm Desert, CA.

The recall was initiated because the salicylic acid in the product is subpotent, meaning it contains less of the active ingredient than labeled. This is an FDA Class III recall, which indicates that use of the product is not likely to cause adverse health consequences.

The affected lots are N0211A (Expiry 07/12), N0214A (Expiry 08/12), N0284A (Expiry 10/12), N0285A (Expiry 10/12), and N0286A (Expiry 10/12). The product was distributed nationwide in the U.S., including Puerto Rico and Guam, as well as in Canada. Consumers should check their lot numbers and stop using the product if it matches the recalled lots.

The recalled product

Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 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
5,025

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 (9)

  • Lot #: N0211A
  • Expiry: 07/12
  • Lot #: N0214A
  • Expiry: 08/12
  • Lot #: N0284A
  • Expiry: 10/12
  • Lot #: N0285A
  • Lot #: N0286A
  • Expiry: 10/12.

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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