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Drug recall · FDA · Published April 1, 2019

Lupin Pharmaceuticals Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,

Lupin Pharmaceuticals recalls 80mg/5mg Telmisartan and Amlodipine tablets due to impurities that could cause serious injury. Rx-only bottles with specific NDC numbers and expiration dates are affected.

🇺🇸 FDA recall #D-1121-2019DrugLupin Pharmaceuticals ›
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Contact the company & request your remedy

Recalling firmLupin Pharmaceuticals Inc.111 S Calvert St Fl 21ST, N/A · Baltimore, MD 21202-6174
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

Lupin Pharmaceuticals is recalling 80 mg/5 mg Telmisartan and Amlodipine tablets (30-count) because impurities may cause serious injury. This recall applies to prescription-only bottles with specific NDC numbers and expiration dates. Read more at govinfonow.com/recall/39041-lupin-telmisartan-amlodipine-tablets-80mg-5mg-recall-impurities-risk-serious.

Source Summary by GovInfoNow · govinfonow.com/recall/39041-lupin-telmisartan-amlodipine-tablets-80mg-5mg-recall-impurities-risk-serious · Updated October 5, 2026 · FDA enforcement record: FDA #D-1121-2019

Cite this page

“Lupin Telmisartan/Amlodipine Tablets 80mg/5mg Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39041-lupin-telmisartan-amlodipine-tablets-80mg-5mg-recall-impurities-risk-serious. Based on FDA recall #D-1121-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1121-2019%22&limit=1).

Why it’s dangerous

The tablets failed impurities and degradation specifications in a 18-month stability study. This could lead to serious injury if the medication is taken as intended.

Who’s affected

Prescription patients who received the recalled 80 mg/5 mg Telmisartan and Amlodipine tablets from Lupin Pharmaceuticals. Those with the specific NDC numbers and expiration dates listed are most at risk.

How to tell if you have this one

Check for the NDC number 68180-198-06 on the bottle. The recall includes prescription-only bottles with expiration dates of April 2019, August 2019, or November 2019.

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

What to do — step by step

  1. Check Product Details

    Look for the NDC number 68180-198-06 on the bottle label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the product failed impurities and degradation specifications, but no specific remedy is provided. Consult your doctor if you have concerns.

How can I tell if I have the recalled product?

Check for the NDC number 68180-198-06 and expiration dates of April 2019, August 2019, or November 2019.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact your doctor or pharmacist for advice.

Take action

Contact Lupin Pharmaceuticals

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

Subject: Recall D-1121-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals

Hello,

I own a Lupin Pharmaceuticals that is covered by recall D-1121-2019 from Lupin Pharmaceuticals.

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-1121-2019 (April 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1121-2019 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