---
title: "Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bot... — FDA record D-0192-2025 | Is It on Recall"
description: "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."
url: https://isitonrecall.com/recall/fda-drug-d-0192-2025-metformin-hydrochloride-extended-release-tablets-usp-500-mg-1000-count-bottles-rx-only-manufactured/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules... — FDA record D-0192-2025

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 30, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class II
- **Recalling firm**: Granules Pharmaceuticals Inc.
- **Quantity**: 6,804 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0192-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0192-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #: 4911311A, Exp. Date: 11/2025 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distributor in OH.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Jan 15, 2025
- **Recall initiation date**: Dec 30, 2024
- **Center classification date**: Jan 8, 2025
- **Termination date**: Jan 15, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0192-2025%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Metformin records](https://isitonrecall.com/drug/metformin/) [Medications records](https://isitonrecall.com/category/medications/) [Granules Pharmaceuticals Inc. records](https://isitonrecall.com/brand/granules-pharmaceuticals-inc/)