“Viatris Candesartan Cilexetil Tablets 16mg Recall: Impurities Risk Serious Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35856-viatris-candesartan-cilexetil-tablets-16mg-recall-impurities-risk-serious-harm. Based on FDA recall #D-0798-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0798-2021%22&limit=1).
The FDA announced on September 13, 2021, that Viatris is recalling Candesartan Cilexetil Tablets, USP 16 mg, manufactured for Mylan Pharmaceuticals Inc., due to failed impurity specifications. The recall involves 21,094 units distributed nationwide.
The product failed impurity and degradation specifications, specifically being out of specification for Related Compound. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Viatris has one other recall on record since August 23, 2021: the Lyrica CR 330mg Tablets Recall for failed dissolution specifications. Other recent recalls of similar products include the Xanax XR 3mg Tablets Recall (March 17, 2026) and the Cinacalcet Tablets Recall (November 14, 2025).
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.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.