Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Lidocaine Patch 5% Recalled for Incorrect or Missing Expiration and Lot Codes

Agency Publication Date: August 10, 2020

Summary

Teva Pharmaceuticals USA is recalling 28,596 cartons of Lidocaine Patch 5%, a prescription medication used for pain relief. While the outer 30-count cartons are labeled correctly, the individual transdermal pouches inside may have incorrect or missing lot numbers and expiration dates. This recall affects Lidocaine Patch 5% distributed nationwide under NDC 0591-3525-30, manufactured by Actavis Laboratories UT, Inc.

Risk

Incorrect or missing labeling on individual medication pouches can lead to the use of expired products or hinder the ability to identify specific patches in the event of a future safety issue. This poses a risk to patients who may inadvertently use a product that is no longer potent or safe.

What You Should Do

Check your medication packaging for Lidocaine Patch 5% in 30-count cartons with NDC 0591-3525-30.
Locate the lot and expiration information on both the outer carton and the individual pouches inside. Affected products include Carton Lot 1383513B (Patch Lot 1383513) with an expiration date of 03/2022.
If you have a patch pouch with missing or incorrect information that does not match the carton, contact your healthcare provider or pharmacist for guidance on whether to continue use.
Return any unused or incorrectly labeled product to your pharmacy to request a refund.
Contact Teva Pharmaceuticals USA at their distributor address (400 Interpace Pkwy, Parsippany, NJ 07054) for further instructions regarding this recall.
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

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Lidocaine Patch 5% (30-count carton)

Model:

NDC 0591-3525-30

Recall #: D-1492-2020

Lot Numbers:

1383513B (Carton Lot)

1383513 (Patch Lot)

Date Ranges: 03/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86017

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 28,596 cartons

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 packaging for Lidocaine Patch 5% in 30-count cartons with NDC 0591-3525-30.

Locate the lot and expiration information on both the outer carton and the individual pouches inside. Affected products include Carton Lot 1383513B (Patch Lot 1383513) with an expiration date of 03/2022.

If you have a patch pouch with missing or incorrect information that does not match the carton, contact your healthcare provider or pharmacist for guidance on whether to continue use.

Return any unused or incorrectly labeled product to your pharmacy to request a refund.

Contact Teva Pharmaceuticals USA at their distributor address (400 Interpace Pkwy, Parsippany, NJ 07054) for further instructions regarding this recall.

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