# FDA recall D-0100-2023

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2022-12-12.

## Product

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

## Reason for recall

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0100-2023
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-12-12
- **Report date:** 2023-01-18
- **Termination date:** 2024-01-31

- **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-0100-2023

## Citation

> AI Analytics. FDA recall D-0100-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0100-2023. Source: US FDA. Licensed CC0.

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