# FDA recall D-0543-2024

> **Zydus Pharmaceuticals (USA) Inc** · Class III · drug recall initiated 2024-05-16.

## Product

Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0543-2024
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-16
- **Report date:** 2024-06-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2024

## Citation

> AI Analytics. FDA recall D-0543-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0543-2024. Source: US FDA. Licensed CC0.

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