CLASS II Drug recall · Reported 17 Jul 2024 · FDA Enforcement Report
Blemfree All Day Lotion (salicylic acid 0.5% w/w) recalled by Equibal
Equibal is recalling Blemfree All Day Lotion (salicylic acid 0.5% w/w), distributed nationwide in the US. The recall was initiated on 26 Jun 2024 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-0591-2024
- FDA event ID
- 94843
- Recalling firm
- Equibal, Unionville, NY
- Brand
- Blemfree
- Manufacturer
- Equibal, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2024
- FDA classified
- 9 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 9 Jul 2024 | Classified by FDA | +13 days |
| 17 Jul 2024 | 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
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Product as listed by the FDA
Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc
Where it was distributed
Nationwide in the USA via internet sales.
Questions about this recall
Why was it recalled?
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Which lots are affected?
Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
Where was it sold?
Nationwide in the USA via internet sales.
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.