# FDA recall D-0633-2024

> **Taro Pharmaceuticals U.S.A., Inc.** · Class III · drug recall initiated 2024-08-07.

## Product

Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01

## Reason for recall

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

## Distribution

Product was distributed to one distributor

## Key facts

- **Recall number:** D-0633-2024
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-08-07
- **Report date:** 2024-08-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0633-2024

## Citation

> AI Analytics. FDA recall D-0633-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0633-2024. Source: US FDA. Licensed CC0.

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