# FDA recall D-1052-2016

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

## Product

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

## Reason for recall

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

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1052-2016
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-04
- **Report date:** 2016-07-06
- **Termination date:** 2017-06-01

- **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-1052-2016

## Citation

> AI Analytics. FDA recall D-1052-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1052-2016. Source: US FDA. Licensed CC0.

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