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Use caution Drug recall · FDA · Published July 31, 2024

Glenmark Recalls Indomethacin 75mg Capsules Due to Dissolution Failure

Glenmark recalls Indomethacin Extended-Release Capsules, USP, 75 mg due to failed dissolution specifications. Check your lot number and NDC for details.

🇺🇸 FDA recall #D-0643-2024DrugGlenmark Pharmaceuticals ›
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Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr · Mahwah, NJ 07430-2009
✎ GovInfoNow plain-language explainer

Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Indomethacin Extended-Release Capsules, USP, 75 mg because they failed dissolution specifications. This means the medication may not release its active ingredient properly, potentially affecting how well it works for patients. The recall covers 2,404 bottles distributed nationwide in the USA. Read more at govinfonow.com/recall/32577-glenmark-recalls-indomethacin-75mg-capsules-due-to-dissolution-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/32577-glenmark-recalls-indomethacin-75mg-capsules-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0643-2024

Cite this page

“Glenmark Recalls Indomethacin 75mg Capsules Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32577-glenmark-recalls-indomethacin-75mg-capsules-due-to-dissolution-failure. Based on FDA recall #D-0643-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0643-2024%22&limit=1).

The FDA announced on July 31, 2024, that Glenmark Pharmaceuticals Inc., USA is recalling Indomethacin Extended-Release Capsules, USP, 75 mg due to failed dissolution specifications. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: Glenmark Pharmaceuticals
  • Product: Indomethacin Extended-Release Capsules, USP, 75 mg
  • NDC 68462-325-60 (60-count bottle)
  • NDC 68462-325-90 (90-count bottle)
  • Lot#: 17240105
  • Exp 12/31/2025

The hazard

The recall is due to below specification results in dissolution testing. The FDA stated that the capsules may not release the drug as intended, potentially affecting efficacy.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since November 20, 2017. Recent similar recalls include Glenmark Azelaic Acid Gel 15% Recall (July 23, 2026), Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026), and Glenmark Ondansetron Tablets Recall (December 30, 2025). Other recent recalls of similar products include Sun Pharmaceutical Lisdexamfetamine Capsules Recall (October 28, 2025), Supernus Trokendi XR 50mg Capsules: Failed Dissolution Specifications Recall (August 31, 2026), and Harvard Drug Group Memantine Capsules Recall (March 24, 2026).

How to tell if you have this one

Check if you have Indomethacin Extended-Release Capsules, USP, 75 mg manufactured by Glenmark Pharmaceuticals Limited. Look for NDC 68462-325-60 (60-count bottle) or NDC 68462-325-90 (90-count bottle). The affected lot number is 17240105 with an expiration date of 12/31/2025.

  • Brand
    Glenmark Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your Indomethacin capsules match the recalled NDCs (68462-325-60 or 68462-325-90) and lot number 17240105.

  2. Contact Your Pharmacist

    Speak with your pharmacist or healthcare provider to determine if you have the recalled product and discuss alternative treatment options.

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 USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Jul 31, 202412. FDA classified it Class II: Aug 23, 202423. Published in FDA’s Enforcement Report: Sep 4, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-0643-2024 (July 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0643-2024 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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