# FDA recall D-0198-2026

> **Teva Pharmaceuticals USA, Inc** · Class III · drug recall initiated 2025-11-07.

## Product

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30.  Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only,  Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

## Reason for recall

Defective Container - A defect in the side-seal which allows leakage of product.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0198-2026
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-07
- **Report date:** 2025-12-10

- **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-0198-2026

## Citation

> AI Analytics. FDA recall D-0198-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0198-2026. Source: US FDA. Licensed CC0.

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