Atomoxetine Capsules HCL recall
FDA recall D-0538-2026 · initiated Apr 30, 2026
Safecor Health, LLC recalled Atomoxetine Capsules HCL in Apr 2026 — an FDA Class II recall (D-0538-2026) because Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 149 capsules
Details
- 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
- Recalling company
- Safecor Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- TX only
- Initiated
- Apr 30, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was Atomoxetine Capsules HCL recalled?
- Safecor Health, LLC recalled Atomoxetine Capsules HCL in Apr 2026 — an FDA Class II recall (D-0538-2026) because Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Atomoxetine Capsules HCL recalled?
- Per the FDA enforcement record, the reason for recall D-0538-2026 was: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- Is a recalled Atomoxetine Capsules HCL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Atomoxetine Capsules HCL are affected?
- Distributed: TX only. The recall covers these lots — Lot #: 25530722. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0538-2026.