# FDA recall D-0089-2024

> **Taro Pharmaceuticals Inc.** · Class III · drug recall initiated 2023-11-06.

## Product

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1

## Reason for recall

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0089-2024
- **Recalling firm:** Taro Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-11-06
- **Report date:** 2023-11-15
- **Termination date:** 2024-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brampton, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0089-2024

## Citation

> AI Analytics. FDA recall D-0089-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0089-2024. Source: US FDA. Licensed CC0.

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