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Lower risk Drug recall · FDA · Published October 5, 2021

Dr. Reddy's Omeprazole Capsules Recall: Staple Found in Bottles

Dr. Reddy's recalls 20 mg omeprazole capsules due to customer complaints about staples found inside bottles. Affected units contain a staple co-mingled with capsules.

🇺🇸 FDA recall #D-0026-2022DrugDr. 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 20 mg omeprazole delayed-release capsules after customer complaints reported finding a staple inside some bottles. This could cause injury if the staple is accidentally ingested. Read more at govinfonow.com/recall/35799-dr-reddy-s-omeprazole-capsules-recall-staple-found-in-bottles.

Source Summary by GovInfoNow · govinfonow.com/recall/35799-dr-reddy-s-omeprazole-capsules-recall-staple-found-in-bottles · Updated August 18, 2026 · FDA enforcement record: FDA #D-0026-2022

Cite this page

“Dr. Reddy's Omeprazole Capsules Recall: Staple Found in Bottles.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35799-dr-reddy-s-omeprazole-capsules-recall-staple-found-in-bottles. Based on FDA recall #D-0026-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0026-2022%22&limit=1).

The FDA announced on 2021-10-05 that Dr. Reddy's Laboratories, Inc. voluntarily recalled Omeprazole Delayed-Release Capsules due to CGMP deviations involving a staple found in the product.

How to tell if you have it

  • Brand: Dr. Reddy's
  • Product: Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules
  • NDC: 70000-0232-1
  • Lot code: BT001594C
  • Distributed by Cardinal Health, Dublin, OH 43017
  • Quantity: 8,976 bottles

The hazard

The recall was initiated following a customer complaint regarding the presence of a staple co-mingled with capsules within the bottle. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has had 85 other recalls on record since 2012-04-09. Recent brand-specific recalls include the 2025-11-11 Varenicline Tablets Recall for subpotent drug risk, the 2025-09-26 Succinylcholine Chloride Injection Recall for stability testing issues, and the 2025-06-30 Omeprazole Capsules Recall for foreign tablets found. Other recent recalls of similar products include Hikma Ramipril Capsules 10mg Recall (2026-08-24), Asclemed Duloxetine Capsules Recall (2026-05-14), and Zydus Clomipramine Capsules Recall (2025-10-22).

How to tell if you have this one

Check for the product name 'Omeprazole Delayed-Release Capsules, 20 mg', 24-hour, 14-count bottles with NDC 70000-0232-1. The product was distributed by Cardinal Health in the U.S.

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

What to do — step by step

  1. Check for Staples

    Inspect the bottle for any staples that may have been co-mingled with the capsules.

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 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 14 months after the firm started it.

1. Firm started the recall: Oct 5, 202112. FDA classified it Class II: Oct 22, 202123. Published in FDA’s Enforcement Report: Oct 27, 202134. FDA terminated the recall: Dec 6, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  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.

✎ GovInfoNow

Questions people ask

Is this product dangerous if I take it?

The recall is due to customer complaints about staples found inside bottles, not a safety issue with the product itself. Taking the capsules as directed should be safe.

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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-0026-2022 (October 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0026-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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