---
title: "Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... — FDA record D-0895-2022 | Is It on Recall"
description: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits ."
url: https://isitonrecall.com/recall/fda-drug-d-0895-2022-losartan-pot-hctz-100-25-mg-90-tabs-ndc-72189-289-90-packaged-and-distributed-by-direct-rx-dawsonvil/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg... — FDA record D-0895-2022

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 May 11, 2022. 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**: Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
- **Reason**: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- **Classification**: Class II
- **Recalling firm**: Direct Rx
- **Quantity**: 11 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0895-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0895-2022%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 | Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25 |

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

## Distribution

FL

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

- [Florida](https://isitonrecall.com/state/florida/)

## Dates in the source

- **Report date**: Jun 1, 2022
- **Recall initiation date**: May 11, 2022
- **Center classification date**: May 24, 2022
- **Termination date**: Dec 2, 2022

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-0895-2022%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

[Losartan records](https://isitonrecall.com/drug/losartan/) [Medications records](https://isitonrecall.com/category/medications/) [Direct Rx records](https://isitonrecall.com/brand/direct-rx/)