# FDA recall D-1057-2020

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2020-03-23.

## Product

Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

## Reason for recall

Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1057-2020
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-23
- **Report date:** 2020-04-01
- **Termination date:** 2021-07-07

- **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-1057-2020

## Citation

> AI Analytics. FDA recall D-1057-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1057-2020. Source: US FDA. Licensed CC0.

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