Medications & Supplements/Prescription Drugs

SUN PHARMACEUTICAL INDUSTRIES INC: Clonazepam Orally Disintegrating Tablets Recalled for Cross Contamination

Agency Publication Date: July 30, 2020

Summary

Sun Pharmaceutical Industries Inc. is recalling 3,516 bottles of Clonazepam Orally Disintegrating Tablets (0.125 mg) because they may be contaminated with another drug, clozapine. This cross-contamination was discovered during routine quality testing when an unknown impurity was identified. This prescription medication, used to treat seizures and panic disorders, was distributed nationwide in 60-count bottles.

Risk

Consumers taking this product may inadvertently ingest clozapine, a potent antipsychotic medication. This cross-contamination could lead to unexpected side effects or dangerous drug interactions, especially for patients who are not intended to be on clozapine therapy.

What You Should Do

Check your medication bottle to see if it is Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg in a 60-count bottle (NDC 57664-783-86).
Verify the specific lot information on the label: look for Lot number AA84106 with an expiration date of 9/2021.
If your bottle matches this lot number, contact your healthcare provider or pharmacist immediately for guidance on safely continuing your treatment.
Return any unused product from this lot to your pharmacy for a refund and further instructions.
Contact Sun Pharmaceutical Industries Inc. at their Princeton, New Jersey headquarters for more information regarding this voluntary recall.
For additional questions or to report a side effect, 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

Healthcare consultation and 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: Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg (60-count bottle)

Model:

NDC 57664-783-86

Lot Numbers:

AA84106 (Exp 9/2021)

Date Ranges: Exp 9/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85995

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Manufactured In: United States

Units Affected: 3516 bottles

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.

Summary

What You Should Do

Check your medication bottle to see if it is Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg in a 60-count bottle (NDC 57664-783-86).

Verify the specific lot information on the label: look for Lot number AA84106 with an expiration date of 9/2021.

If your bottle matches this lot number, contact your healthcare provider or pharmacist immediately for guidance on safely continuing your treatment.

Return any unused product from this lot to your pharmacy for a refund and further instructions.

Contact Sun Pharmaceutical Industries Inc. at their Princeton, New Jersey headquarters for more information regarding this voluntary recall.

For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.