Atomoxetine Capsules Recall Due to Labeling Mix-Up
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drug.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (877 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.