# FDA recall D-1406-2020

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2020-07-02.

## Product

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

## Reason for recall

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1406-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-02
- **Report date:** 2020-07-29
- **Termination date:** 2021-06-30

- **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-1406-2020

## Citation

> AI Analytics. FDA recall D-1406-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1406-2020. Source: US FDA. Licensed CC0.

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