Glenmark Indomethacin Capsules: Incorrect Dosage Labeling Risk
Glenmark Pharmaceuticals recalls 50mg indomethacin capsules with incorrect adult dosage instructions. Labels state 'one or two capsules 2-3 times daily' instead of 'one capsule 2-3 times daily'. This could lead to overdose risk if taken as instructed.
Lower-risk recall
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
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What happened, in plain English
Glenmark Pharmaceuticals is recalling 50mg indomethacin capsules that have incorrect dosage labels. The labels say to take 'one or two capsules 2 or 3 times a day' instead of the correct 'one capsule 2 or 3 times a day'. This could lead to taking too many pills and potential overdose risk. Read more at govinfonow.com/recall/40775-glenmark-indomethacin-capsules-incorrect-dosage-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40775-glenmark-indomethacin-capsules-incorrect-dosage-labeling-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0606-2018
Cite this page
“Glenmark Indomethacin Capsules: Incorrect Dosage Labeling Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40775-glenmark-indomethacin-capsules-incorrect-dosage-labeling-risk. Based on FDA recall #D-0606-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0606-2018%22&limit=1).
Why it’s dangerous
The labels incorrectly state the adult dosage as 'one or two capsules 2 or 3 times a day' instead of the correct 'one capsule 2 or 3 times a day'. This could lead to taking more pills than intended, potentially causing overdose.
Who’s affected
Prescription users of indomethacin capsules who received the recalled lot numbers. Those taking the medication as labeled could risk overdose if they follow the incorrect instructions.
How to tell if you have this one
Check for the product name 'Indomethacin Capsules USP, 50 mg, 100-count bottle' with the lot numbers listed: 19172776, 19172794 (exp 07/19), 19173111, 19173186, 19173188, 19173189 (exp 08/19), 19173852, 19173878, 19173893 (exp 10/19), 19174318, 19174341 (exp 11/19).
- Brand
Glenmark- Category
Drug
What to do — step by step
Check Label Instructions
Verify the dosage instructions on the label. The correct adult dosage is 'one capsule 2 or 3 times a day' not 'one or two capsules 2 or 3 times a day'.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in 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 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
The recall does not require immediate action. Check the label instructions to ensure you are taking the correct dosage. If unsure, contact your healthcare provider.
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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-0606-2018 (March 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0606-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.