# FDA recall D-0097-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2024-11-01.

## Product

Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.

## Reason for recall

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0097-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-01
- **Report date:** 2024-12-11

- **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-0097-2025

## Citation

> AI Analytics. FDA recall D-0097-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0097-2025. Source: US FDA. Licensed CC0.

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