# FDA recall D-0034-2018

> **AbbVie Inc.** · Class III · drug recall initiated 2017-09-08.

## Product

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only.  Marketed by:  AbbVie Inc., North Chicago, IL 60064 USA.  NDC:  0051-8462-30

## Reason for recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

## Distribution

AZ

## Key facts

- **Recall number:** D-0034-2018
- **Recalling firm:** AbbVie Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-08
- **Report date:** 2017-11-01
- **Termination date:** 2018-04-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2018

## Citation

> AI Analytics. FDA recall D-0034-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0034-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*