Blemfree Lotion
FDA Recall NDC 53228-003
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Blemfree (NDC 53228-003). A significant event, classified as Class II, was initiated on Jun 26, 2024 by Equibal, Inc.. The reported reason for this action was: "CGMP Deviations: Manufactured without following Current Good Manufacturing Practises."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Jun 26, 2024
Jul 17, 2024
90/1 oz. tubes and 248/4 oz. bottles
Recall Profile & Regulatory Data
Event ID
94843
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Equibal Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA via internet sales.
Termination Date
Apr 07, 2026
Product Description
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
Batch or Lot Expiration Information
Lot# a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
Affected Packages Involved in this Recall
53228-003-01Product
53228-002-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
