# FDA recall D-0088-2022

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2021-10-12.

## Product

Irbesartan Tablets USP, 300 mg  a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

## Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

## Distribution

Product was distributed to major distributors who may have further distributed the product nationwide.

## Key facts

- **Recall number:** D-0088-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-12
- **Report date:** 2021-11-10
- **Termination date:** 2023-01-30

- **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-0088-2022

## Citation

> AI Analytics. FDA recall D-0088-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0088-2022. Source: US FDA. Licensed CC0.

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