# FDA recall D-0245-2025

> **Alvogen, Inc** · Class I · drug recall initiated 2025-01-31.

## Product

Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.

## Reason for recall

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0245-2025
- **Recalling firm:** Alvogen, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-01-31
- **Report date:** 2025-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morristown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2025

## Citation

> AI Analytics. FDA recall D-0245-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0245-2025. Source: US FDA. Licensed CC0.

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