Atomoxetine Capsules HCL — Class II drug recall D-0538-2026
Ongoing recall by Safecor Health, LLC, reported 2026-05-27, distributed in TX. Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
| Recall number | D-0538-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safecor Health, LLC, Columbus, OH, United States |
| Recall initiated | 2026-04-30 |
| Classified | 2026-05-18 |
| Reported by FDA | 2026-05-27 |
| Distributed | TX |
| Quantity | 149 capsules |
| Reason classes | labeling |
| NDC | 64380-0472, 64380-0472-01, 64380-0472-02, 64380-0473, 64380-0473-01, 64380-0473-02, 64380-0474, 64380-0474-01, 64380-0474-02, 64380-0475, 64380-0475-01, 64380-0475-02, 64380-0476, 64380-0476-01, 64380-0476-02, 64380-0477, 64380-0477-01, 64380-0477-05, 64380-0478, 64380-0478-01, 64380-0478-02 |
| Lot numbers | 25530722 |
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 for recall
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0538-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.