# FDA recall D-1536-2022

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2022-09-13.

## Product

Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03

## Reason for recall

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

## Distribution

Product was distributed to major distributors/wholesalers nationwide.

## Key facts

- **Recall number:** D-1536-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-13
- **Report date:** 2022-09-21
- **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-1536-2022

## Citation

> AI Analytics. FDA recall D-1536-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-1536-2022. Source: US FDA. Licensed CC0.

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