Atomoxetine Capsules Recall Due to Labeling Mix-Up

Source: FDA · Texas

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Safecor Health, LLC is recalling 149 Atomoxetine HCl 10 mg capsules in Texas after a label mix-up with 25 mg capsules.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 10, 2026 and geographically references Texas. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Safecor Health, LLC initiated a voluntary recall of Atomoxetine Capsules after a labeling mix-up was identified. Atomoxetine HCl 25 mg capsules were incorrectly labeled as Atomoxetine HCl 10 mg capsules.

Which Products Are Affected

The recall affects Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips packed in cartons of 100, Rx Only, packaged by Safecor, Columbus, OH 43204. NDC: 64380-474-01. Lot #: 25530722. A total of 149 capsules are involved. Distribution was limited to TX only.

What You Should Do

Consumers in possession of the affected lot should stop using the product and contact Safecor Health, LLC or their pharmacist for return or refund instructions.

Why This Matters

The mislabeling creates a risk of incorrect dosing for patients prescribed atomoxetine.

Source

FDA recall number D-0538-2026 (Class II).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Safecor Health, LLC is recalling 149 Atomoxetine HCl 10 mg capsules in Texas after a label mix-up with 25 mg capsules.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Texas. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.