# FDA recall D-1289-2022

> **Teva Pharmaceuticals USA Inc** · Class II · drug recall initiated 2022-06-29.

## Product

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30

## Reason for recall

Superpotent Drug: Out of specification assay result was obtained during stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1289-2022
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-29
- **Report date:** 2022-08-03
- **Termination date:** 2024-03-15

- **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-1289-2022

## Citation

> AI Analytics. FDA recall D-1289-2022. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/D-1289-2022. Source: US FDA. Licensed CC0.

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