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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: Clozapine Tablets Recalled for Broken Tablets and Failed Specifications

Agency Publication Date: November 27, 2017
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Summary

Teva Pharmaceuticals USA has recalled 3,870 bottles of Clozapine (100 mg) tablets because some tablets in these bottles may be broken or fail to meet manufacturing specifications. Clozapine is a prescription medication used to treat certain mental health conditions. Consumers who have these 500-count bottles should check their packaging immediately to ensure their medication is intact and safe to use. Because the dosage of a broken tablet cannot be guaranteed, you should contact your doctor or pharmacist if you find damaged pills in your supply.

Risk

Taking broken tablets can result in receiving an incorrect dose of medication, which may lead to a loss of symptom control or an increased risk of side effects. This defect specifically involves a failure in tablet physical specifications that occurred during the manufacturing process.

What You Should Do

  1. Check your prescription bottle to see if it is Clozapine Tablets USP, 100 mg, in a 500-count bottle with NDC 00093-7772-05.
  2. Look for Lot # 39C192 with an expiration date of 06/2019 printed on the label.
  3. If you identify an affected bottle, inspect the tablets for any signs of breakage or damage.
  4. Contact your healthcare provider or pharmacist for guidance before you stop taking the medication, as stopping this drug abruptly can have serious health consequences.
  5. Return any unused or damaged product to the pharmacy where it was purchased for a refund.
  6. Contact Teva Pharmaceuticals USA at 1-888-838-2872 for further instructions regarding this recall.
  7. 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

Healthcare consultation and pharmacy return.

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

Affected Products

Product: Clozapine Tablets USP, 100 mg (500 count bottles)
Model:
NDC 00093-7772-05
Recall #: D-0096-2018
Lot Numbers:
39C192 (exp 06/2019)
Date Ranges: Expiration: 06/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78552
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: pharmacies; healthcare providers
Manufactured In: Israel, United States
Units Affected: 3,870 bottles
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.