CLASS III Drug recall · Reported 7 Oct 2015 · FDA Enforcement Report
Rodan & Fields Proactiv Solution recalled by Guthy-Renker
Guthy-Renker is recalling Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne, distributed nationwide in the US. The recall was initiated on 7 May 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0003-2016
- FDA event ID
- 72089
- Recalling firm
- Guthy-Renker, Palm Desert, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 May 2012
- FDA classified
- 1 Oct 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 May 2012 | Recall initiated by company | |
| 1 Oct 2015 | Classified by FDA | +1242 days |
| 7 Oct 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Salicylic acid is subpotent.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide including Puerto Rico and Guam; Canada.
Questions about this recall
Why was it recalled?
Subpotent Drug: Salicylic acid is subpotent.
Which lots are affected?
Lot #: N0211A, Expiry: 07/12; Lot #: N0214A, Expiry: 08/12; Lot #: N0284A, Expiry: 10/12; Lot #: N0285A, Expiry: 10/12; Lot #: N0286A, Expiry: 10/12.
Where was it sold?
U.S. Nationwide including Puerto Rico and Guam; Canada.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 72089| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide | |
| CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide | |
| CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide | |
| CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
More recalls from Guthy-Renker
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
Other Rodan & Fields Proactiv recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |
| Drug | CLASS III | Rodan & Fields Proactiv Solution recalled by Guthy-Renker | Guthy-Renker | Potency & Assay | Nationwide |