Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Esomeprazole Magnesium Capsules Recalled for Product Discoloration

Agency Publication Date: April 28, 2020

Summary

Dr. Reddy's Laboratories, Inc. has voluntarily recalled 1,752 bottles of Esomeprazole Magnesium (esomeprazole magnesium) Delayed-Release Capsules, USP, 40 mg. This prescription medication is being recalled because the product contains brown pellets instead of the expected color, indicating discoloration and potential quality issues. These 1000-count bottles were distributed nationwide within the United States.

Risk

The presence of brown pellets in the medication indicates the product has become discolored or degraded, which could potentially affect the drug's effectiveness or lead to unexpected reactions.

What You Should Do

Check your medication bottle to see if it is Esomeprazole Magnesium Delayed-Release Capsules, 40 mg, in a 1000-count bottle with NDC 43598-510-10.
Verify the bottle for lot number C900642 with an expiration date of 06/2020.
If your medication matches this lot number and description, contact your healthcare provider or pharmacist immediately for guidance on your treatment.
Return any unused portions of the affected medication to your pharmacy for a refund and further instruction.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office or through their consumer customer service channels regarding this recall.
For additional questions or to report side effects, 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

Refund and guidance for prescription medication

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

Affected Products

Product: Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg (1000-count bottle)

Model:

NDC 43598-510-10

Recall #: D-1256-2020

Lot Numbers:

C900642 (Exp. 06/2020)

Date Ranges: 06/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85557

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 1752 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 Esomeprazole Magnesium Delayed-Release Capsules, 40 mg, in a 1000-count bottle with NDC 43598-510-10.

Verify the bottle for lot number C900642 with an expiration date of 06/2020.

If your medication matches this lot number and description, contact your healthcare provider or pharmacist immediately for guidance on your treatment.

Return any unused portions of the affected medication to your pharmacy for a refund and further instruction.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office or through their consumer customer service channels regarding this recall.

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