# FDA recall D-0065-2021

> **Aurobindo Pharma USA Inc.** · Class III · drug recall initiated 2020-10-22.

## Product

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92

## Reason for recall

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension  is missing dosing cups.

## Distribution

NJ

## Key facts

- **Recall number:** D-0065-2021
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-22
- **Report date:** 2020-11-11
- **Termination date:** 2023-04-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0065-2021

## Citation

> AI Analytics. FDA recall D-0065-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0065-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*