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Drug recall · FDA · Published March 22, 2021

Macleods Pharma Usa Inc recalls Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc.,

Macleods Pharma recalls 4mg Candesartan tablets due to failed impurities. Affected lots from ECD5908C to ECD5912A, expiring 07/2021 and 09/2021. Stop using if you have these specific lots.

🇺🇸 FDA recall #D-0329-2021DrugMacleods ›
Take action

Contact the company & request your remedy

Recalling firmMacleods Pharma Usa Inc666 Plainsboro Rd Bldg 200 Ste 230, N/A · Plainsboro, NJ 08536-0009
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

Macleods Pharma is recalling 4mg Candesartan Cilexetil tablets that may have failed impurities. This could pose a health risk to people taking the medication. Affected products were manufactured for specific lots with expiration dates through September 2021. Read more at govinfonow.com/recall/36256-macleods-candesartan-tablets-recall-failed-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36256-macleods-candesartan-tablets-recall-failed-impurities-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0329-2021

Cite this page

“Macleods Candesartan Tablets Recall: Failed Impurities Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36256-macleods-candesartan-tablets-recall-failed-impurities-risk. Based on FDA recall #D-0329-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0329-2021%22&limit=1).

Why it’s dangerous

The tablets may contain impurities that failed quality specifications. This could lead to health risks for people using the medication as prescribed. The exact nature of the impurities is not specified in the recall.

Who’s affected

People who have prescription Candesartan Cilexetil tablets from Macleods Pharma with the specific lots mentioned. Those taking blood pressure medication are most at risk.

How to tell if you have this one

Check your prescription bottle for the lot numbers ECD5908C through ECD5912A. Products with expiration dates of July 2021 or September 2021 are affected.

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

What to do — step by step

  1. Check Your Product

    Look for lot numbers ECD5908C through ECD5912A on the bottle label.

✎ GovInfoNow

Questions people ask

Do I need to stop using these tablets?

The recall does not specify a stop-use instruction. Check your lot number to see if it's affected.

What should I do if I have the affected lot?

The recall does not provide a remedy for affected products. Contact your doctor or pharmacist for advice.

Are there any specific expiration dates for these tablets?

Yes, affected products expire by July 2021 or September 2021.

Take action

Contact Macleods

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

Subject: Recall D-0329-2021 — Macleods Macleods

Hello,

I own a Macleods that is covered by recall D-0329-2021 from Macleods.

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-0329-2021 (March 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0329-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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