---
title: "Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ... — FDA record D-0392-2022 | Is It on Recall"
description: "CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit."
url: https://isitonrecall.com/recall/fda-drug-d-0392-2022-metformin-hydrochloride-extended-release-tablets-usp-750-mg-100-count-hdpe-bottles-ndc-72578-036-01/
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 750 mg, 100 count HDPE bottles NDC# 72578-036-01 — FDA record D-0392-2022

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 27, 2021. 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 750 mg, 100 count HDPE bottles NDC# 72578-036-01
- **Reason**: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- **Classification**: Class II
- **Recalling firm**: VIONA PHARMACEUTICALS INC
- **Quantity**: 23,8416/100 count bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0392-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0392-2022%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 | M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023 |

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

## Distribution

Product was distributed to 17 wholesalers who further distributed the product to 85 locations.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 2, 2022
- **Recall initiation date**: Dec 27, 2021
- **Center classification date**: Jan 21, 2022
- **Termination date**: Sep 20, 2023

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-0392-2022%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/) [VIONA PHARMACEUTICALS INC records](https://isitonrecall.com/brand/viona-pharmaceuticals-inc/)