# FDA recall D-0247-2021

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2021-01-21.

## Product

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01

## Reason for recall

Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0247-2021
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-21
- **Report date:** 2021-02-10
- **Termination date:** 2021-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2021

## Citation

> AI Analytics. FDA recall D-0247-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0247-2021. Source: US FDA. Licensed CC0.

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