CLASS II Drug recall · Reported 25 May 2016 · FDA Enforcement Report
Better Braids Un-braid (salicylic acid), Le Demelant recalled
Keystone Laboratories is recalling Better Braids Un-braid (salicylic acid), Le Demelant, distributed in Maryland, New Jersey. The recall was initiated on 4 Apr 2016 and the FDA has classified it as Class II.
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-0853-2016
- FDA event ID
- 73895
- Recalling firm
- Keystone Laboratories, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2016
- FDA classified
- 16 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 4 Apr 2016 | Recall initiated by company | |
| 16 May 2016 | Classified by FDA | +42 days |
| 25 May 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
Where it was distributed
U.S. Including: MD and NJ
Questions about this recall
Is Better Braids Un-braid (salicylic acid), Le Demelant recalled?
Yes. Keystone Laboratories recalled Better Braids Un-braid (salicylic acid), Le Demelant on 4 Apr 2016. The recall is Class II and its status is Terminated. Recall number D-0853-2016.
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Which lots are affected?
Lot #: 10AN5
Where was it sold?
U.S. Including: MD and NJ
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Keystone Laboratories
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Medicated Better Braids, La Laque (salicylic acid) Spray recalled | Keystone Laboratories | Sterility | Nationwide |
| Food | CLASS III | LONG AID Curl Activator Gel recalled by Keystone LaboratoriesLong AID | Keystone Laboratories | Other | 10 states |