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Drug recall · FDA · Published March 25, 2019

Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot

Glenmark Pharmaceuticals recalls 20mg Pravastatin tablets due to foreign tablets in some bottles. This may cause harm if taken. Check your bottle's NDC 68462-196-05 and lot number 17181491.

🇺🇸 FDA recall #D-1120-2019DrugGlenmark ›
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Contact the company & request your remedy

Recalling firmGlenmark Pharmaceuticals Inc., USA750 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 is recalling 20mg Pravastatin Sodium Tablets in 500-count bottles because foreign tablets may be present. This could cause harm if taken, so affected users should check their bottles and contact the manufacturer. Read more at govinfonow.com/recall/39071-glenmark-pravastatin-tablets-recall-foreign-tablet-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/39071-glenmark-pravastatin-tablets-recall-foreign-tablet-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-1120-2019

Cite this page

“Glenmark Pravastatin Tablets Recall: Foreign Tablet Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39071-glenmark-pravastatin-tablets-recall-foreign-tablet-hazard. Based on FDA recall #D-1120-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1120-2019%22&limit=1).

Why it’s dangerous

Foreign tablets can be present in the bottle, which may cause harm if taken. The hazard is not described as causing serious injury or death in normal use, but could lead to adverse effects from taking the wrong tablets.

Who’s affected

People with a prescription for Pravastatin Sodium Tablets 20mg 500-count bottles from Glenmark Pharmaceuticals Inc. in the US. Those who have the specific NDC 68462-196-05 and lot number 17181491 are most at risk.

How to tell if you have this one

Check for the NDC code 68462-196-05 and lot number 17181491 on the bottle. The product was manufactured in India and distributed in the US by Glenmark Pharmaceuticals Inc.

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

What to do — step by step

  1. Check Your Bottle

    Look for the NDC code 68462-196-05 and lot number 17181491 on the bottle label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states foreign tablets may be present, which could cause harm if taken. The manufacturer does not provide a specific remedy, so affected users should check their bottles and contact the manufacturer.

What should I do if I have this product?

Check your bottle for the NDC code 68462-196-05 and lot number 17181491. If you have the product, contact Glenmark Pharmaceuticals Inc. for further instructions.

How can I confirm if my product is recalled?

Look for the NDC code 68462-196-05 and lot number 17181491 on the bottle. The product was manufactured in India and distributed in the US by Glenmark Pharmaceuticals Inc.

Take action

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-1120-2019 — Glenmark Glenmark

Hello,

I own a Glenmark that is covered by recall D-1120-2019 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-1120-2019 (March 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1120-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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