# FDA recall D-0301-2020

> **Taro Pharmaceuticals U.S.A., Inc.** · Class II · drug recall initiated 2019-09-27.

## Product

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free,  8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532,  NDC 51672-2130-1

## Reason for recall

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0301-2020
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-27
- **Report date:** 2019-11-06
- **Termination date:** 2023-08-31

- **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-0301-2020

## Citation

> AI Analytics. FDA recall D-0301-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0301-2020. Source: US FDA. Licensed CC0.

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