Medications & Supplements/Topical Products

Preferred Pharmaceuticals, Inc.: Lidothol Patch Recalled Due to Missing Manufacturing and Test Records

Agency Publication Date: July 15, 2020

Summary

Preferred Pharmaceuticals, Inc. is recalling Lidothol Patch (lidocaine 4.5% and menthol 5%), a topical anesthetic and analgesic used for pain relief. The recall was initiated because the contract manufacturer lost the essential batch records and quality test results required to ensure the product meets safety and potency standards. Without these records, the company cannot verify that the medication was manufactured correctly or is safe for use.

Risk

Missing manufacturing records mean there is no documented proof that the patches contain the correct amount of active ingredients or are free from contaminants. This creates a risk that the product may be ineffective or cause unexpected skin reactions or other side effects due to unverified quality control.

What You Should Do

Locate your box of Lidothol Patch (Lidocaine 4.5% & Menthol 5%) and check for the following lot numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, or G0519G.
Verify if the expiration date on the packaging is 5/31/2021.
If your product matches these lot numbers and expiration date, stop using the patches immediately.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.
Return any unused patches to the pharmacy where you purchased them for a refund.
Contact Preferred Pharmaceuticals, Inc. at their Anaheim, California location for further instructions regarding this recall.
For additional questions or to report a problem, 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

Affected Products

Product: Lidothol Patch, Lidocaine 4.5% & Menthol 5% (15 patches per box)

Model:

68788-7405-01

53225-1025-01

Lot Numbers:

H0218Z

H1518J

I2018L

J2918C

L1018Q

A0419M

G0519G

Date Ranges: Exp: 5/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86002

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: The Physicians Solutions; Preferred Pharmaceuticals, Inc.

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

Risk

What You Should Do

Locate your box of Lidothol Patch (Lidocaine 4.5% & Menthol 5%) and check for the following lot numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, or G0519G.

Verify if the expiration date on the packaging is 5/31/2021.

If your product matches these lot numbers and expiration date, stop using the patches immediately.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.

Return any unused patches to the pharmacy where you purchased them for a refund.

Contact Preferred Pharmaceuticals, Inc. at their Anaheim, California location for further instructions regarding this recall.

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