Medications & Supplements/Topical Products

Blemfree All Day Lotion Recalled for Manufacturing Practice Deviations

Agency Publication Date: July 9, 2024

Summary

Equibal Inc has recalled Blemfree All Day Lotion (salicylic acid 0.5% w/w) because it was manufactured without following Current Good Manufacturing Practices (CGMP). This recall affects 90/1 oz. tubes and 248/4 oz. bottles of the acne treatment lotion. Because the product was not made under standard safety and quality controls, its purity and effectiveness cannot be guaranteed.

Risk

Failure to follow proper manufacturing standards means the product may not contain the stated amount of active ingredients or could be contaminated. This could lead to ineffective treatment of skin conditions or unexpected skin irritation.

What You Should Do

The recalled products are Blemfree All Day Lotion (salicylic acid 0.5% w/w) sold in 1 oz. tubes and 4 oz. plastic bottles under the Equibal Labs brand.
Check your packaging for lot codes BF063221 (with expiration date 03/04/2025) or BF097221 (with expiration date 04/07/2025).
The 1 oz. tubes have NDC 53228-003-01. The 4 oz. bottles have NDC 53228-002-01 and UPC 701450900086.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Blemfree All Day Lotion (1 oz. 29 ML tube)by Equibal Labs, Inc

Variants: salicylic acid 0.5% w/w, 1 oz. tube

Lot Numbers:

BF063221 (Exp 03/04/2025)

BF097221 (Exp 04/07/2025)

NDC:

53228-003-01

Quantity affected: 90 tubes.

Product: Blemfree All Day Lotion (4 OZ 118ML plastic bottle)by Equibal Labs, Inc

Variants: salicylic acid 0.5% w/w, 4 oz. bottle

UPC Codes:

701450900086

Lot Numbers:

BF097221 (Exp 04/07/2025)

NDC:

53228-002-01

Quantity affected: 248 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94843

Status: Resolved

Manufacturer: Equibal Inc

Sold By: internet sales

Manufactured In: United States

Units Affected: 90/1 oz. tubes and 248/4 oz. bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products are Blemfree All Day Lotion (salicylic acid 0.5% w/w) sold in 1 oz. tubes and 4 oz. plastic bottles under the Equibal Labs brand.

Check your packaging for lot codes BF063221 (with expiration date 03/04/2025) or BF097221 (with expiration date 04/07/2025).

The 1 oz. tubes have NDC 53228-003-01. The 4 oz. bottles have NDC 53228-002-01 and UPC 701450900086.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Blemfree All Day Lotion (1 oz. 29 ML tube)by Equibal Labs, Inc

Variants: salicylic acid 0.5% w/w, 1 oz. tube

Lot Numbers:

BF063221 (Exp 03/04/2025)

BF097221 (Exp 04/07/2025)

NDC:

53228-003-01

Quantity affected: 90 tubes.

Product: Blemfree All Day Lotion (4 OZ 118ML plastic bottle)by Equibal Labs, Inc

Variants: salicylic acid 0.5% w/w, 4 oz. bottle

UPC Codes:

701450900086

Lot Numbers:

BF097221 (Exp 04/07/2025)

NDC:

53228-002-01

Quantity affected: 248 bottles.