CLASS III Drug recall · Reported 8 Jan 2020 · FDA Enforcement Report
PCA Skin Blemish Control Bar, Salicylic acid recalled
Island Kinetics, Inc. d.b.a. CoValence Laboratories is recalling PCA Skin Blemish Control Bar, Salicylic acid 2% - Acne cleanser, For external use only, distributed in Arizona. The recall was initiated on 20 Dec 2019 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-0634-2020
- FDA event ID
- 84561
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories, Chandler, AZ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Dec 2019
- FDA classified
- 31 Dec 2019
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
Timeline
| 20 Dec 2019 | Recall initiated by company | |
| 31 Dec 2019 | Classified by FDA | +11 days |
| 8 Jan 2020 | 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
Superpotent Drug: Salicylic acid content is above the firm's specification.
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
PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
Where it was distributed
AZ
Questions about this recall
Is PCA Skin Blemish Control Bar, Salicylic acid 2% - Acne cleanser, For external use only recalled?
Yes. Island Kinetics, Inc. d.b.a. CoValence Laboratories recalled PCA Skin Blemish Control Bar, Salicylic acid 2% - Acne cleanser, For external use only on 20 Dec 2019. The recall is Class III and its status is Terminated. Recall number D-0634-2020.
Why was it recalled?
Superpotent Drug: Salicylic acid content is above the firm's specification.
Which lots are affected?
Batch number: L041918A, Exp. 04/2021 Lot # F9518B2
Where was it sold?
AZ
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.