---
title: "Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... — FDA record D-0441-2023 | 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-0441-2023-metformin-hydrochloride-extended-release-tablets-1000-mg-60-count-bottle-rx-only-manufactured-by-act/
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, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laborat... — FDA record D-0441-2023

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 Feb 22, 2023. 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, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
- **Reason**: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- **Classification**: Class II
- **Recalling firm**: Teva Pharmaceuticals USA Inc
- **Quantity**: 12,044 Bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0441-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0441-2023%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 #: 1410946A; Exp. 06/2023 |

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

## Distribution

CA

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

- [California](https://isitonrecall.com/state/california/)

## Dates in the source

- **Report date**: Mar 15, 2023
- **Recall initiation date**: Feb 22, 2023
- **Center classification date**: Mar 7, 2023
- **Termination date**: Dec 6, 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-0441-2023%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/) [Teva Pharmaceuticals USA Inc records](https://isitonrecall.com/brand/teva-pharmaceuticals-usa-inc/)