# FDA recall D-0510-2025

> **Granules Pharmaceuticals Inc.** · Class II · drug recall initiated 2025-06-24.

## Product

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

## Reason for recall

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0510-2025
- **Recalling firm:** Granules Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-24
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chantilly, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2025

## Citation

> AI Analytics. FDA recall D-0510-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0510-2025. Source: US FDA. Licensed CC0.

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