# FDA recall D-1503-2016

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2016-04-06.

## Product

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.

## Reason for recall

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

## Distribution

All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin.  No recalled product was distributed to any foreign consignees by Lupin.

## Key facts

- **Recall number:** D-1503-2016
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-06
- **Report date:** 2016-09-28
- **Termination date:** 2017-08-07

- **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-1503-2016

## Citation

> AI Analytics. FDA recall D-1503-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1503-2016. Source: US FDA. Licensed CC0.

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