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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 Orally Disintegrating Tablets Recalled for Failed Disintegration

Agency Publication Date: October 1, 2018
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Summary

Teva Pharmaceuticals USA is recalling 313 bottles of Clozapine Orally Disintegrating Tablets (12.5 mg) because the tablets did not break down correctly during routine quality testing. When tablets do not disintegrate as required, they may not provide the intended dose of medication or may be difficult to swallow. The affected products are 100-count bottles containing yellow, round tablets marked with the number '13'. This recall was initiated after stability testing showed the drug was not meeting performance specifications.

Risk

The tablets may fail to dissolve properly in the mouth, which can lead to improper absorption of the medication and reduced effectiveness in treating underlying conditions. There is also a potential risk for patients who have difficulty swallowing if the tablet remains solid longer than expected.

What You Should Do

  1. Check your prescription bottle label to see if you have Clozapine Orally Disintegrating Tablets, 12.5 mg (NDC 0093-5416-01).
  2. Look for Lot # 34034024B with an expiration date of 02/20 on the side of the bottle.
  3. Identify the tablets: they are yellow, round, flat-faced, with beveled edges, and debossed with the number '13' on one side.
  4. Contact your healthcare provider or pharmacist immediately for guidance and to ensure your medication schedule is not interrupted.
  5. Return any unused product from this specific lot to the pharmacy where it was purchased to receive a refund.
  6. Contact Teva Pharmaceuticals USA for further instructions regarding the return of the affected tablets.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and clinical guidance.

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

Affected Products

Product: Clozapine Orally Disintegrating Tablets (12.5 mg, 100-count bottles)
Model:
NDC 0093-5416-01
Recall #: D-0001-2019
Lot Numbers:
34034024B (Exp 02/20)
Date Ranges: Expiration 02/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81068
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies; Hospitals; Healthcare Providers
Manufactured In: United States
Units Affected: 313 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.