# FDA recall D-0430-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2024-03-26.

## Product

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01

## Reason for recall

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0430-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-03-26
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0430-2024

## Citation

> AI Analytics. FDA recall D-0430-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0430-2024. Source: US FDA. Licensed CC0.

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