# FDA recall D-0280-2025

> **MYLAN PHARMACEUTICALS INC** · Class II · drug recall initiated 2025-02-25.

## Product

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

## Reason for recall

Failed Dissolution Specifications - low dissolution results

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0280-2025
- **Recalling firm:** MYLAN PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-02-25
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0280-2025

## Citation

> AI Analytics. FDA recall D-0280-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0280-2025. Source: US FDA. Licensed CC0.

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