# FDA recall D-1150-2022

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2022-06-10.

## Product

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

## Reason for recall

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

## Distribution

Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.

## Key facts

- **Recall number:** D-1150-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-10
- **Report date:** 2022-06-22
- **Termination date:** 2023-02-08

- **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-1150-2022

## Citation

> AI Analytics. FDA recall D-1150-2022. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/D-1150-2022. Source: US FDA. Licensed CC0.

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