Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Clozapine Tablets Recalled for Potential 50mg Tablet in 100mg Bottles

Agency Publication Date: June 24, 2020

Summary

Aurobindo Pharma USA Inc. is recalling 1,440 bottles of Clozapine (clozapine) Tablets USP, 100mg dosage, because a consumer reported finding a 50mg tablet inside a 100mg bottle. This recall affects 500-count bottles of the prescription medication from a specific production lot distributed nationwide in the United States. Taking an incorrect dosage of this medication can lead to serious health complications or ineffective treatment.

Risk

Patients may inadvertently take a 50mg dose instead of their prescribed 100mg dose, or vice versa if they rely on tablet appearance. This dosage error can lead to a loss of symptom control or an increased risk of side effects associated with clozapine.

What You Should Do

Check your medication bottle for Clozapine Tablets USP, 100mg in 500-count bottles with NDC 65862-846-05.
Verify if your bottle belongs to Lot Number CZSC20003-A with an expiration date of 1/2022.
If you identify a 50mg tablet (which may look different in size, color, or markings) inside your 100mg bottle, or if you have a bottle from the affected lot, contact your healthcare provider or pharmacist immediately for guidance.
Return any unused product from the affected lot to your pharmacy for a refund and contact Aurobindo Pharma USA Inc. for further instructions.
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

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, 100mg (500-count bottle)

Model:

NDC 65862-846-05

Lot Numbers:

CZSC20003-A (Exp 1/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85852

Status: Resolved

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 1440 bottles

Distributed To: Nationwide

Agency Last Updated: June 30, 2020

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 bottle for Clozapine Tablets USP, 100mg in 500-count bottles with NDC 65862-846-05.

Verify if your bottle belongs to Lot Number CZSC20003-A with an expiration date of 1/2022.

If you identify a 50mg tablet (which may look different in size, color, or markings) inside your 100mg bottle, or if you have a bottle from the affected lot, contact your healthcare provider or pharmacist immediately for guidance.

Return any unused product from the affected lot to your pharmacy for a refund and contact Aurobindo Pharma USA Inc. for further instructions.

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.