CLASS III Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid recalled
Genesis Pharmaceutical is recalling Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, distributed nationwide in the US. The recall was initiated on 1 Apr 2014 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-1285-2014
- FDA event ID
- 68098
- Recalling firm
- Genesis Pharmaceutical, Henderson, NV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Apr 2014
- FDA classified
- 29 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 1 Apr 2014 | Recall initiated by company | |
| 29 Apr 2014 | Classified by FDA | +28 days |
| 7 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
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
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Which lots are affected?
Lot 54, Exp: 1/14/2016
Where was it sold?
Nationwide
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.