Viatris recalls 25mg Carvedilol tablets due to weight and thickness exceeding specifications. This may affect medication accuracy. Check NDC 0378-3634-05 for affected lots.
“Viatris Carvedilol Tablets 25mg Recall: Weight/Thickness Issues.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34236-viatris-carvedilol-tablets-25mg-recall-weight-thickness-issues. Based on FDA recall #D-0063-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0063-2023%22&limit=1).
The FDA announced on Oct. 21, 2022, that Viatris Inc. is recalling Carvedilol Tablets, USP, 25 mg, in 500-count bottles due to failed tablet specifications. The agency classified the recall as Class II.
According to the FDA, the tablets exceed specifications for weight and thickness. The recall is classified as Class II.
Context
GovInfoNow's records show Viatris, Inc. has had 10 other recalls on record since April 28, 2022. Other recent recalls of similar products include Viatris Xanax XR 3mg Tablets Recall (March 17, 2026), Viatris Cardura XL 8mg Tablets Recall (Dec. 23, 2024), and Viatris Levothyroxine Tablets Recall (Nov. 18, 2024). Other recent recalls of similar products include Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026), Vitruvias Thyroid Tablets Recall (Aug. 21, 2026), and Unichem busPIRone 5mg Tablets Recall (April 13, 2026).
How to tell if you have this one
Check for the NDC code 0378-3634-05 on the bottle label. The lot number 3150116 was made in India and expires February 2025.
Brand
Viatris
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Look for the NDC code 0378-3634-05 on the bottle label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-0063-2023 (October 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0063-2023 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.