# FDA recall D-1438-2019

> **Amneal Pharmaceuticals, Inc.** · Class III · drug recall initiated 2017-09-25.

## Product

Esterified Estrogens & Methyltestosterone Tablets, USP  0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01

## Reason for recall

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1438-2019
- **Recalling firm:** Amneal Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-25
- **Report date:** 2019-07-10
- **Termination date:** 2019-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brookhaven, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1438-2019

## Citation

> AI Analytics. FDA recall D-1438-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1438-2019. Source: US FDA. Licensed CC0.

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