# FDA recall D-0199-2026

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2025-11-21.

## Product

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

## Reason for recall

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0199-2026
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-21
- **Report date:** 2025-12-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0199-2026

## Citation

> AI Analytics. FDA recall D-0199-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0199-2026. Source: US FDA. Licensed CC0.

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