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Lower risk Drug recall · FDA · Published April 24, 2020

Dr. Red: Esomeprazole Capsules Recalled Due to Brown Pellets

Dr. Reddy's recalls 40mg esomeprazole capsules with brown pellets. No immediate risk but discoloration may indicate quality issues.

🇺🇸 FDA recall #D-1256-2020DrugDr. Reddy's ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
✎ GovInfoNow plain-language explainer

Dr. Reddy's is recalling 40mg esomeprazole capsules that contain brown pellets. This discoloration could indicate quality issues but does not pose an immediate health risk. Read more at govinfonow.com/recall/37131-dr-red-esomeprazole-capsules-recalled-due-to-brown-pellets.

Source Summary by GovInfoNow · govinfonow.com/recall/37131-dr-red-esomeprazole-capsules-recalled-due-to-brown-pellets · Updated October 5, 2026 · FDA enforcement record: FDA #D-1256-2020

Cite this page

“Dr. Red: Esomeprazole Capsules Recalled Due to Brown Pellets.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37131-dr-red-esomeprazole-capsules-recalled-due-to-brown-pellets. Based on FDA recall #D-1256-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1256-2020%22&limit=1).

The FDA announced on April 24, 2020, that Dr. Reddy's Laboratories, Inc. voluntarily recalled Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg, due to discoloration hazards. The agency classified the recall as Class III.

How to tell if you have it

  • Brand: Dr. Reddy's
  • Product: Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*
  • Packaging: 1000-count bottles
  • NDC: 43598-510-10
  • Lot #: C900642
  • Expiration: 06/2020
  • Manufacturer: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA

The hazard

According to the FDA, the product contains brown pellets, constituting a discoloration hazard.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since April 9, 2012. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (Nov. 11, 2025), Dr. Reddy's Succinylcholine Chloride Injection Recall (Sept. 26, 2025), and Dr. Reddy's Omeprazole Capsules Recall (June 30, 2025). Other recent recalls of similar products include Shilpa Medicare Recalls PEMRYDI RTU Injections Due to Green Discoloration (July 29, 2026) and Breckenridge Duloxetine Capsules Recall (April 21, 2026).

How to tell if you have this one

Check for brown pellets in the capsules. The product is a 40mg esomeprazole capsule bottle with NDC 43598-510-10, manufactured in India by Dr. Reddy's Laboratories.

  • Brand
    Dr. Reddy's
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Capsule Appearance

    Inspect capsules for brown pellets. If present, do not use the product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Apr 24, 202012. FDA classified it Class III: Apr 28, 202023. Published in FDA’s Enforcement Report: May 6, 202034. FDA terminated the recall: May 13, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1256-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1256-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA