# FDA recall D-0063-2023

> **Viatris Inc** · Class II · drug recall initiated 2022-10-21.

## Product

Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

## Reason for recall

Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0063-2023
- **Recalling firm:** Viatris Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-10-21
- **Report date:** 2022-11-23
- **Termination date:** 2023-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canonsburg, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0063-2023

## Citation

> AI Analytics. FDA recall D-0063-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0063-2023. Source: US FDA. Licensed CC0.

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