Medications & Supplements/Topical Products

DLC Laboratories, Inc: Sulfur Ointment Recalled Due to Labeling Mix-Up

Agency Publication Date: February 12, 2021

Summary

DLC Laboratories, Inc. is recalling approximately 86,297 jars of De La Cruz Sulfur Ointment 10% (Pomada de Azufre) in 2.6 oz sizes. The recall was initiated because the English "Drug Facts" panel for Camphor was incorrectly placed on the Sulfur product. This labeling error provides consumers with the wrong active ingredient information and incorrect usage instructions, which could lead to improper application. These products were distributed nationwide in the United States and to several foreign countries including Canada, Germany, and the United Kingdom.

Risk

Using a product with an incorrect Drug Facts label means consumers may follow directions or safety warnings for the wrong medication (Camphor instead of Sulfur). This mix-up increases the risk of improper use or potential adverse skin reactions due to incorrect application instructions.

What You Should Do

Check your product to see if it is De La Cruz Sulfur Ointment 10% (Pomada de Azufre) in a 2.6 oz (73.7g) jar.
Look for UPC 024286150426 on the packaging to determine if your product is included in this recall.
Check the lot number and expiration date on your jar for any of the following: Lot 5084 (Exp 05/23), Lot 5130 (Exp 07/23), Lot 5132 (Exp 07/23), or Lot 5160 (Exp 08/23).
Inspect the back label of the jar; if the English 'Drug Facts' panel lists Camphor as the active ingredient instead of Sulfur, the product is mislabeled.
Contact your healthcare provider or pharmacist for guidance if you have used the incorrectly labeled ointment.
Return any unused product to the place of purchase for a refund and contact DLC Laboratories at their Paramount, California facility for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Sulfur Ointment 10%, Pomada de Azufre (2.6 OZ / 73.7g) jar

UPC Codes:

024286150426

Lot Numbers:

5084 (Exp 05/23)

5130 (Exp 07/23)

5132 (Exp 07/23)

5160 (Exp 08/23)

Date Ranges: Expiration 05/23, Expiration 07/23, Expiration 08/23

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87257

Status: Resolved

Manufacturer: DLC Laboratories, Inc

Manufactured In: United States

Units Affected: 86,297 jars

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

Check your product to see if it is De La Cruz Sulfur Ointment 10% (Pomada de Azufre) in a 2.6 oz (73.7g) jar.

Look for UPC 024286150426 on the packaging to determine if your product is included in this recall.

Check the lot number and expiration date on your jar for any of the following: Lot 5084 (Exp 05/23), Lot 5130 (Exp 07/23), Lot 5132 (Exp 07/23), or Lot 5160 (Exp 08/23).

Inspect the back label of the jar; if the English 'Drug Facts' panel lists Camphor as the active ingredient instead of Sulfur, the product is mislabeled.

Contact your healthcare provider or pharmacist for guidance if you have used the incorrectly labeled ointment.

Return any unused product to the place of purchase for a refund and contact DLC Laboratories at their Paramount, California facility for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.