CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%) recalled
Milbar Laboratories is recalling B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), Dermatologic Cosmetic Laboratories, distributed in Puerto Rico. The recall was initiated on 4 May 2018 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-0811-2018
- FDA event ID
- 80042
- Recalling firm
- Milbar Laboratories, East Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 4 May 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +11 days |
| 23 May 2018 | 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
Microbial Contamination of Non-sterile Product
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
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Where it was distributed
Within the United States and Puerto Rico
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-sterile Product
Which lots are affected?
Lot: # ET507-0, Exp. 5/27/2019; GU894-8, Exp. 7/20/2010
Where was it sold?
Within the United States and Puerto Rico
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 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
3 other products · FDA event 80042This product is part of a recall event; the main page for the event is MD Complete Clarifying Cleanser (Salicylic Acid 2.0%) recalled.
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|---|---|---|---|---|---|
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| Drug | CLASS II | DCL Active Mattifying Cleanser recalled by Milbar Laboratories | Milbar Laboratories | Processing Deviation | Nationwide |
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