# FDA recall D-0188-2024

> **CARDINAL HEALTHCARE** · Class II · drug recall initiated 2022-01-26.

## Product

Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India.  NDC:   68180-518-01

## Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0188-2024
- **Recalling firm:** CARDINAL HEALTHCARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-26
- **Report date:** 2024-01-03
- **Termination date:** 2024-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0188-2024

## Citation

> AI Analytics. FDA recall D-0188-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0188-2024. Source: US FDA. Licensed CC0.

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