# FDA recall D-0100-2021

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2020-11-11.

## Product

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT  84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054.

## Reason for recall

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

## Distribution

Product was distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0100-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2020-11-25
- **Termination date:** 2021-06-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2021

## Citation

> AI Analytics. FDA recall D-0100-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0100-2021. Source: US FDA. Licensed CC0.

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