Glenmark Pharmaceuticals Inc., USA recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b)
Glenmark Pharmaceuticals recalls 20mg esomeprazole capsules due to impurities detected at 18 months in stability testing. Consumers should check NDC 68462-390-30 or 68462-390-10 bottles for affected lots.
Lower-risk recall
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Contact the company & request your remedy
What happened, in plain English
Glenmark Pharmaceuticals is recalling 20mg esomeprazole magnesium delayed-release capsules because impurities were found in long-term stability testing at 18 months. This could pose a health risk if the medication is taken after this time period. Read more at govinfonow.com/recall/33033-glenmark-esomeprazole-capsules-recall-impurities-risk-in-long-term-storage.
Source Summary by GovInfoNow · govinfonow.com/recall/33033-glenmark-esomeprazole-capsules-recall-impurities-risk-in-long-term-storage · Updated September 23, 2026 · FDA enforcement record: FDA #D-0112-2024
Cite this page
“Glenmark Esomeprazole Capsules Recall: Impurities Risk in Long-Term Storage.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33033-glenmark-esomeprazole-capsules-recall-impurities-risk-in-long-term-storage. Based on FDA recall #D-0112-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2024%22&limit=1).
Why it’s dangerous
The recall is based on impurities detected in the medication after 18 months of storage under standard conditions. This could mean the medication is no longer safe for use after the expiration date, potentially causing health issues if taken.
Who’s affected
People who have the 30-count or 1000-count bottles of esomeprazole capsules with NDC numbers 68462-390-30 or 68462-390-10. Those taking the medication for acid reflux or ulcers are most at risk if the capsules are used after the expiration date.
How to tell if you have this one
Check for bottles labeled 'Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg' with NDC codes 68462-390-30 (30-count) or 68462-390-10 (1000-count). The product was manufactured for Glenmark Pharmaceuticals in India and expires November 30, 2023.
- Brand
Glenmark- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC codes 68462-390-30 or 68462-390-10 on the bottle to confirm if it's affected.
Questions people ask
Why is this medication being recalled?
The recall is due to impurities detected in the medication after 18 months of storage in long-term stability testing, which could affect safety.
Is this medication safe to take?
The medication may not be safe after the expiration date, but the recall is based on testing results, not immediate safety concerns.
How do I know if I have the recalled product?
Check for bottles with NDC codes 68462-390-30 (30-count) or 68462-390-10 (1000-count) and the expiration date of November 30, 2023.
Contact Glenmark
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0112-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0112-2024 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0112-2024 (October 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0112-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.