# FDA recall D-0542-2018

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2018-01-29.

## Product

Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72),  Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.

## Reason for recall

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

## Distribution

Distributed nationwide within the United States

## Key facts

- **Recall number:** D-0542-2018
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-29
- **Report date:** 2018-02-14
- **Termination date:** 2018-09-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2018

## Citation

> AI Analytics. FDA recall D-0542-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0542-2018. Source: US FDA. Licensed CC0.

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