The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0004-2016·Announced 2015-10-07

Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation

Guthy-Renker LLC is recalling specific lots of 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Guthy-Renker LLC is recalling 4,526 compacts of Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. The recall involves specific lots with lot numbers N0012A, N0257A, N0258A, and N0259A, with expiry dates of 01/12 and 09/12.

The recall was initiated because the salicylic acid in the product is subpotent, meaning it contains less of the active ingredient than labeled. The U.S. Food and Drug Administration has classified this as a Class III recall, indicating that use of the product is not likely to cause adverse health consequences.

The affected products were distributed nationwide in the U.S., including Puerto Rico and Guam, as well as in Canada. Consumers should check their products for the specific lot numbers and expiry dates listed above. If the product matches the recalled lots, consumers should stop using it and follow the instructions provided by the recalling firm.

The recalled product

Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 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
4,526

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 #: N0012A
  • Expiry: 01/12
  • Lot #: N0257A
  • Expiry: 09/12
  • Lot #: N0258A
  • Lot #: N0259A
  • Expiry: 09/12.

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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