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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Clonazepam Orally Disintegrating Tablets Recalled for Failed Water Content Tests

Agency Publication Date: October 18, 2018
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Summary

Teva Pharmaceuticals USA is recalling 1,373 cartons of Clonazepam Orally Disintegrating Tablets USP (2 mg) because the medication failed routine stability testing for water content. This prescription drug, used to treat certain seizure and anxiety disorders, may not meet quality standards throughout its shelf life due to this moisture issue. Consumers who have the affected 60-count cartons from the specific lot should be aware of this quality defect and take appropriate action to ensure their medication remains effective.

Risk

The tablets failed testing for water content, which can compromise the stability and chemical integrity of the medication over time. This may result in the drug losing its potency or failing to perform as expected before its expiration date.

What You Should Do

  1. Identify your medication by checking the package for Clonazepam Orally Disintegrating Tablets USP, 2 mg, in 60-count cartons with NDC 0555-0098-96.
  2. Check the side or bottom of the carton for Lot Number 34033752A and an expiration date of 1/2020.
  3. If your medication matches this lot number, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if necessary.
  4. Return any unused tablets from this specific lot to your pharmacy to receive a refund.
  5. Contact Teva Pharmaceuticals USA directly for further instructions regarding this recall.
  6. 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

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton
Model:
NDC 0555-0098-96
Recall #: D-0082-2019
Lot Numbers:
34033752A (EXP 1/2020)
Date Ranges: Expiration Date: 1/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81069
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: distributors
Manufactured In: United States
Units Affected: 1,373 60-count 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 ยท 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.