# FDA recall D-0192-2025

> **Granules Pharmaceuticals Inc.** · Class II · drug recall initiated 2024-12-30.

## Product

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

## Reason for recall

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

## Distribution

Distributor in OH.

## Key facts

- **Recall number:** D-0192-2025
- **Recalling firm:** Granules Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-12-30
- **Report date:** 2025-01-15
- **Termination date:** 2026-01-15

- **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-0192-2025

## Citation

> AI Analytics. FDA recall D-0192-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0192-2025. Source: US FDA. Licensed CC0.

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