# FDA recall D-0838-2022

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2022-03-31.

## Product

Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC#  68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

## Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

## Distribution

Product was distributed nationwide

## Key facts

- **Recall number:** D-0838-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-31
- **Report date:** 2022-05-11
- **Termination date:** 2023-05-22

- **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-0838-2022

## Citation

> AI Analytics. FDA recall D-0838-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0838-2022. Source: US FDA. Licensed CC0.

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