# FDA recall D-0576-2025

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2025-07-21.

## Product

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

## Reason for recall

Failed Dissolution Specifications: low dissolution results

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0576-2025
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-21
- **Report date:** 2025-08-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2025

## Citation

> AI Analytics. FDA recall D-0576-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0576-2025. Source: US FDA. Licensed CC0.

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