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Drug recall · FDA · Published May 1, 2023

Glenmark Therapeutics, Inc. recalls Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA,

Glenmark Therapeutics recalls 200-count Famotidine tablets that may have incorrect 10mg labeling on cartons. This label error could lead to incorrect dosing if taken without checking the label.

🇺🇸 FDA recall #D-0939-2023DrugGlenmark Therapeutics ›
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Contact the company & request your remedy

Recalling firmGlenmark Therapeutics, Inc.750 Corporate Dr, N/A · Mahwah, NJ 07430-2009
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Therapeutics is recalling 200-count Famotidine tablets that may have a label error showing 10mg instead of 20mg. This could lead to incorrect dosing if users rely on the label without verifying the actual strength. Read more at govinfonow.com/recall/33518-glenmark-famotidine-tablets-20mg-recall-label-error-may-show-10mg.

Source Summary by GovInfoNow · govinfonow.com/recall/33518-glenmark-famotidine-tablets-20mg-recall-label-error-may-show-10mg · Updated September 23, 2026 · FDA enforcement record: FDA #D-0939-2023

Cite this page

“Glenmark Famotidine Tablets 20mg Recall: Label Error May Show 10mg Strength.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33518-glenmark-famotidine-tablets-20mg-recall-label-error-may-show-10mg. Based on FDA recall #D-0939-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0939-2023%22&limit=1).

Why it’s dangerous

The cartons may have an external label indicating 10mg strength instead of the actual 20mg. This label error could lead to users taking fewer tablets than intended, potentially causing underdosing if they rely on the label without verifying the actual strength.

Who’s affected

People who own or use the recalled Famotidine tablets (200-count bottles) distributed by Glenmark Therapeutics in the U.S. are most at risk if they take the tablets without checking the label.

How to tell if you have this one

Check for Famotidine Tablets, USP, 20mg, 200-count bottles with cartons labeled as 10mg on the side. The product was distributed by Glenmark Therapeutics in the U.S. and made in India with NDC 72657-113-20.

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

What to do — step by step

  1. Check Label Carefully

    Verify the actual strength on the carton by checking the label for 20mg instead of 10mg.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

No, this recall is for a label error that could lead to incorrect dosing if users rely on the label without verifying the actual strength. It does not pose a risk of serious injury.

How can I tell if I have the recalled product?

Check for Famotidine Tablets, USP, 20mg, 200-count bottles with cartons labeled as 10mg on the side. The product was distributed by Glenmark Therapeutics in the U.S. and made in India with NDC 72657-113-20.

What should I do if I have the recalled product?

Check the label carefully to verify the strength. If the label shows 10mg, do not take the tablets without confirming the actual strength with a healthcare provider.

Take action

Contact Glenmark Therapeutics

We’ve drafted a message you can send Glenmark Therapeutics to request your refund or repair — edit it as you like.

Subject: Recall D-0939-2023 — Glenmark Therapeutics Glenmark Therapeutics

Hello,

I own a Glenmark Therapeutics that is covered by recall D-0939-2023 from Glenmark Therapeutics.

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-0939-2023 (May 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0939-2023 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.
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