Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Imatinib Mesylate Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: February 24, 2021

Summary

Dr. Reddy's Laboratories is recalling approximately 1,350 bottles and 147 cartons of Imatinib Mesylate tablets (100mg), a prescription medication used to treat certain types of cancer. The recall was initiated because the tablets failed dissolution specifications, meaning they may not dissolve properly in the body as intended. This defect can lead to the medication being less effective than required for treatment. These products were distributed nationwide across the United States in both 90-count bottles and 30-count cartons for institutional use.

Risk

If the medication fails to dissolve correctly, the patient may not receive the full intended dose of the drug. This could result in decreased effectiveness of the cancer treatment, potentially allowing the underlying condition to worsen.

What You Should Do

Check your medication packaging for Imatinib Mesylate Tablets 100mg to see if it matches the affected lot numbers.
Identify affected 90-count bottles (NDC 43598-344-90) by looking for Lot H2000206 with an expiration date of 06/22.
Identify affected 30-count cartons (NDC 43598-344-31) by looking for Lot H2000138 with an expiration date of 06/22.
Immediately contact your healthcare provider or pharmacist for guidance on whether you should continue your current supply or obtain a replacement.
Return any unused or affected medication to your pharmacy to request a refund.
Contact Dr. Reddy's Laboratories at 1-888-723-3332 for further instructions regarding this recall.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

Full Refund

Healthcare provider 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: Imatinib Mesylate Tablets 100mg (90-count bottle)

Model:

NDC 43598-344-90

Lot Numbers:

H2000206 (Exp 06/22)

Date Ranges: Expiration 06/22

Product: Imatinib Mesylate Tablets 100mg (30-count carton)

Model:

NDC 43598-344-31

Lot Numbers:

H2000138 (Exp 06/22)

Date Ranges: Expiration 06/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87339

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: pharmacies; hospitals; institutional providers

Manufactured In: India, United States

Units Affected: a) 1350 bottles; b) 147 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 · 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 packaging for Imatinib Mesylate Tablets 100mg to see if it matches the affected lot numbers.

Identify affected 90-count bottles (NDC 43598-344-90) by looking for Lot H2000206 with an expiration date of 06/22.

Identify affected 30-count cartons (NDC 43598-344-31) by looking for Lot H2000138 with an expiration date of 06/22.

Immediately contact your healthcare provider or pharmacist for guidance on whether you should continue your current supply or obtain a replacement.

Return any unused or affected medication to your pharmacy to request a refund.

Contact Dr. Reddy's Laboratories at 1-888-723-3332 for further instructions regarding this recall.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.