Viatris Candesartan Cilexetil Tablets 16mg Recall: Impurities Risk Serious Harm

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Recalling firmViatris781 Chestnut Ridge Rd, N/A · Morgantown, WV 26505-2730

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Viatris is recalling 16mg Candesartan Cilexetil tablets due to impurities that could cause serious harm. This affects specific batches made in October 2021. Consumers should stop using these products immediately.

Why it’s dangerous

The tablets contain impurities that may cause serious health issues. This happens because the manufacturing process failed to meet safety standards for the drug's purity.

Who’s affected

People who own the recalled 16mg Candesartan Cilexetil tablets from Viatris. Those with high blood pressure or on related medication are at higher risk.

How to tell if you have this one

Check for the 16mg strength, 30-count bottles, and lot number 3107334 with an expiration date of October 2021. The product was manufactured by Viatris for Mylan Pharmaceuticals.

Brand
Viatris
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the recalled tablets as they may contain harmful impurities.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The tablets failed impurities and degradation specifications, making them unsafe for use.

What should I do if I have the recalled product?

Stop using the product immediately and contact Viatris for a replacement.

Are there any other products affected?

No, only the specific 16mg tablets with lot number 3107334 from October 2021.

Take action

Contact Viatris

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

✉️ Open in email

Subject: Recall D-0798-2021 — Viatris Viatris

Hello,

I own a Viatris that is covered by recall D-0798-2021 from Viatris.

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-0798-2021 (September 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0798-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Viatris recalls Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown,

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