Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Esomeprazole Magnesium DR Capsules (40mg) Recalled for Discoloration

Agency Publication Date: February 13, 2019

Summary

Dr. Reddy's Laboratories is recalling 40,592 bottles of Esomeprazole Magnesium Delayed-Release Capsules (40mg), a prescription medication used to treat stomach acid conditions. The recall was initiated because the capsules may contain brown-colored pellets instead of their normal appearance. This recall includes both 90-count and 1,000-count bottles that were distributed nationwide throughout the United States.

Risk

The presence of brown, discolored pellets within the capsules indicates a product defect or degradation. Consuming discolored medication may result in reduced effectiveness of the treatment or unexpected side effects.

What You Should Do

Check your prescription bottle for Esomeprazole Magnesium Delayed-Release Capsules, 40mg with NDC numbers 43598-510-90 (90-count bottle) or 43598-510-10 (1,000-count bottle).
Verify if your bottle matches one of the following affected lots: C800589 (Exp 5/2019), C706058 (Exp 03/2019), C704873 (Exp 02/2019), C800951 (Exp 06/2019), or C800953 (Exp 06/2019).
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to obtain a replacement and ensure your treatment is not interrupted.
Return any unused discolored medication to the pharmacy where it was purchased for a refund and further guidance.
Contact Dr. Reddy's Laboratories at their Princeton, New Jersey office for additional information regarding this firm-initiated recall.
For additional questions or to report adverse 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

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: Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg (90-count bottle)

Model:

NDC 43598-510-90

Lot Numbers:

C800589 (Exp 5/2019)

C706058 (Exp 03/2019)

Date Ranges: Expiration 03/2019, Expiration 05/2019

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

Model:

NDC 43598-510-10

Lot Numbers:

C704873 (Exp 02/2019)

C800951 (Exp 06/2019)

C800953 (Exp 06/2019)

Date Ranges: Expiration 02/2019, Expiration 06/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82065

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: United States, India

Units Affected: 40,592, 90 and 1,000 count bottles

Distributed To: Nationwide

Agency Last Updated: March 12, 2019

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 prescription bottle for Esomeprazole Magnesium Delayed-Release Capsules, 40mg with NDC numbers 43598-510-90 (90-count bottle) or 43598-510-10 (1,000-count bottle).

Verify if your bottle matches one of the following affected lots: C800589 (Exp 5/2019), C706058 (Exp 03/2019), C704873 (Exp 02/2019), C800951 (Exp 06/2019), or C800953 (Exp 06/2019).

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to obtain a replacement and ensure your treatment is not interrupted.

Return any unused discolored medication to the pharmacy where it was purchased for a refund and further guidance.

Contact Dr. Reddy's Laboratories at their Princeton, New Jersey office for additional information regarding this firm-initiated recall.

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

Affected Products

Product: Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg (90-count bottle)

Model:

NDC 43598-510-90

Lot Numbers:

C800589 (Exp 5/2019)

C706058 (Exp 03/2019)

Date Ranges: Expiration 03/2019, Expiration 05/2019

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

Model:

NDC 43598-510-10

Lot Numbers:

C704873 (Exp 02/2019)

C800951 (Exp 06/2019)

C800953 (Exp 06/2019)

Date Ranges: Expiration 02/2019, Expiration 06/2019