# FDA recall D-0860-2022

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class II · drug recall initiated 2022-04-01.

## Product

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16

## Reason for recall

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

## Distribution

Nationwide within USA

## Key facts

- **Recall number:** D-0860-2022
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-01
- **Report date:** 2022-05-18
- **Termination date:** 2023-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0860-2022

## Citation

> AI Analytics. FDA recall D-0860-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0860-2022. Source: US FDA. Licensed CC0.

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