Medications & Supplements/Prescription Drugs

TOLMAR, Inc.: Clindamycin and Benzoyl Peroxide Gel Recalled for Superpotency

Agency Publication Date: December 14, 2021

Summary

TOLMAR, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel (1%/5%), a prescription topical medication used for treating acne. The recall was initiated because the product was found to be superpotent, meaning it contains a higher concentration of the active ingredients than specified. Consumers should immediately stop using the affected gel and contact their healthcare provider or pharmacist for further guidance.

Risk

Superpotent topical medication may lead to increased skin irritation, such as redness, peeling, or burning, and could potentially cause unexpected side effects due to the higher-than-intended concentration of clindamycin and benzoyl peroxide.

What You Should Do

Check your medication container for Clindamycin and Benzoyl Peroxide Gel, 1%/5% in 25 g jars with NDC 0781-7263-68.
Verify the lot numbers and expiration dates on the packaging: Look for lot 11557C1 (Exp. Feb 2022), lot 11552B1 (Exp. Apr 2022), or lot 12206A1 (Exp. Nov 2022).
If your product matches these identifiers, stop using it immediately and contact your healthcare provider or pharmacist for guidance.
Return any unused portion of the recalled medication to your pharmacy for a refund and contact TOLMAR, Inc. for further instructions.
For additional information or to report a concern, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Clindamycin and Benzoyl Peroxide Gel, 1%/5% (25 g jars)

Model:

NDC 0781-7263-68

Lot Numbers:

11557C1 (Exp. Feb 2022)

11552B1 (Exp. Apr 2022)

12206A1 (Exp. Nov 2022)

Date Ranges: Expiration Date: February 2022, Expiration Date: April 2022, Expiration Date: November 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88910

Status: Resolved

Manufacturer: TOLMAR, Inc.

Sold By: pharmacies

Manufactured In: United States

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 medication container for Clindamycin and Benzoyl Peroxide Gel, 1%/5% in 25 g jars with NDC 0781-7263-68.

Verify the lot numbers and expiration dates on the packaging: Look for lot 11557C1 (Exp. Feb 2022), lot 11552B1 (Exp. Apr 2022), or lot 12206A1 (Exp. Nov 2022).

If your product matches these identifiers, stop using it immediately and contact your healthcare provider or pharmacist for guidance.

Return any unused portion of the recalled medication to your pharmacy for a refund and contact TOLMAR, Inc. for further instructions.

For additional information or to report a concern, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).