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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Teva Pharmaceuticals USA: Lidocaine Patch 5% Recalled for Failed Stability Specifications

Agency Publication Date: May 23, 2018
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Summary

Teva Pharmaceuticals USA is recalling 30,382 patches of Lidocaine Patch 5% (700 mg) because the product failed stability specifications during testing. This prescription medication, used to treat pain, may not maintain its required strength or quality through its shelf life, which could impact its effectiveness. If you have this product, you should contact your healthcare provider or pharmacist for guidance on continued use and how to obtain a replacement.

Risk

The failure to meet stability specifications means the medication may not perform as intended over time, potentially leading to inadequate pain relief for patients relying on the patch.

What You Should Do

  1. Identify your product by checking the carton for Lot Number 1147020B and the individual patch envelopes for Lot Number 1147020.
  2. Verify the NDC numbers on the packaging: NDC 0591-3525-11 for individual envelopes and NDC 0591-3525-30 for the 30-patch cartons.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
  4. Return any unused patches from the affected lots to your pharmacy to receive a refund.
  5. Contact Teva Pharmaceuticals USA at their North Wales, Pennsylvania headquarters or through their customer service channels for more information regarding this recall.
  6. 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

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% (700 mg), 30 Patches/Carton
Model:
NDC 0591-3525-11
NDC 0591-3525-30
Lot Numbers:
1147020B (Carton)
1147020 (Patch/Envelope)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80004
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: pharmacies
Manufactured In: United States
Units Affected: 30,382 patches
Distributed To: Nationwide

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.