The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0002-2016·Announced 2015-10-07

Rodan & Fields Proactiv Foundation Recalled for Subpotent Salicylic Acid

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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the hazard is a lack of efficacy rather than a safety risk.

Plain-English summary

Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts. The recall involves 29,341 compacts distributed nationwide in the U.S., including Puerto Rico and Guam, as well as in Canada.

The recall was initiated because the salicylic acid in the product is subpotent, meaning it does not contain the full amount of the active ingredient required for the product to be effective as an acne treatment. The affected lots include N0054A, N0055A, N0201A, N0202A, N0351A, N0354A, N0355A, N1033A, N1046A, N1108A, N1291A, N1319A, and N1320A, with expiry dates ranging from 02/12 to 11/13.

Consumers should stop using the product and check the lot number and expiry date on their compacts to see if they are affected. This is an over-the-counter product manufactured for Guthy-Renker LLC in Palm Desert, CA.

The recalled product

Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 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
29,341

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 (20)

  • Lot #: N0054A
  • Expiry: 02/12
  • Lot #: N0055A
  • Lot #: N0201A
  • Expiry: 07/12
  • Lot #: N0202A
  • Lot #: N0351A
  • Expiry: 12/12
  • Lot #: N0354A
  • 12/12
  • Lot #: N0355A
  • Lot #: N1033A
  • Expiry: 02/13
  • Lot #: N1046A
  • Lot #: N1108A
  • Expiry: 04/13
  • Lot #: N1291A
  • Expiry: 10/13
  • Lot #: N1319A
  • Expiry: 11/13

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 →

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