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Lower risk Drug recall · FDA · Published February 6, 2019

Dr. Reddy's Esomeprazole Capsules Recall: Brown Pellets Risk

Dr. Reddy's recalls 40mg esomeprazole capsules with brown pellets. Discoloration may indicate unsafe product. Check NDC codes for affected lots.

🇺🇸 FDA recall #D-0995-2019DrugDr. 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 recalls 40mg esomeprazole capsules that may contain brown pellets. This discoloration could indicate a safety issue, so affected users should check their product details. Read more at govinfonow.com/recall/39212-dr-reddy-s-esomeprazole-capsules-recall-brown-pellets-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39212-dr-reddy-s-esomeprazole-capsules-recall-brown-pellets-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0995-2019

Cite this page

“Dr. Reddy's Esomeprazole Capsules Recall: Brown Pellets Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39212-dr-reddy-s-esomeprazole-capsules-recall-brown-pellets-risk. Based on FDA recall #D-0995-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0995-2019%22&limit=1).

The FDA announced on Feb. 6, 2019, that Dr. Reddy's Laboratories, Inc. voluntarily recalled Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg, due to potential brown pellet discoloration. The recall affects specific lots distributed nationwide in the USA.

How to tell if you have it

  • Brand: Dr. Reddy's
  • Product: Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg
  • Packaging: 90-count bottle (NDC 43598-510-90) and 1000 count bottle (NDC 43598-510-10)
  • Lot Codes: a) C800589, Exp 5/2019; C706058, Exp 03/2019 b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019
  • Distribution: Nationwide in the USA

The hazard

The capsules may contain brown pellets, which constitutes a discoloration hazard. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (2025-11-11), Dr. Reddy's Succinylcholine Chloride Injection Recall (2025-09-26), and Dr. Reddy's Omeprazole Capsules Recall (2025-06-30). Other recent recalls of similar products include Shilpa Medicare Recalls PEMRYDI RTU Injections Due to Green Discoloration (2026-07-29) and Hikma Ramipril Capsules 10mg Recall (2026-08-24).

How to tell if you have this one

Check for the product name 'Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg' on the bottle. Look for NDC codes 43598-510-90 (90-count) or 43598-510-10 (1000-count).

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

What to do — step by step

  1. Check Product Details

    Identify the product by checking the NDC codes: 43598-510-90 for 90-count bottles or 43598-510-10 for 1000-count bottles.

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: “Distributed Nationwide in the USA” 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 years after the firm started it.

1. Firm started the recall: Feb 6, 201912. Published in FDA’s Enforcement Report: Feb 20, 201923. FDA classified it Class III: Mar 12, 201934. FDA terminated the recall: Jan 26, 2021420192021
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class III
  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-0995-2019 (February 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0995-2019 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