---
title: "Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are ... — FDA record D-0538-2026 | Is It on Recall"
description: "Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule."
url: https://isitonrecall.com/recall/fda-drug-d-0538-2026-atomoxetine-capsules-hcl-10-mg-capsules-in-unit-dose-foil-strip-strips-are-packed-in-cartons-of-100/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg b... — FDA record D-0538-2026

Reported ongoing

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 Apr 30, 2026. 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**: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
- **Reason**: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- **Classification**: Class II
- **Recalling firm**: Safecor Health, LLC
- **Quantity**: 149 capsules
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0538-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0538-2026%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 #: 25530722 |

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

## Distribution

TX only

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

- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: May 27, 2026
- **Recall initiation date**: Apr 30, 2026
- **Center classification date**: May 18, 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-0538-2026%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

[Medications records](https://isitonrecall.com/category/medications/) [Safecor Health, LLC records](https://isitonrecall.com/brand/safecor-health-llc/)