FDA Drug recall D-0538-2026
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus,…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus,… by Safecor Health, citing labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0538-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-30 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Safecor Health |
| Distribution | TX |
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.
Identifiers
| ndc | 64380-472-01 |
|---|---|
| ndc | 64380-472-02 |
| ndc | 64380-473-01 |
| ndc | 64380-473-02 |
| ndc | 64380-474-01 |
| ndc | 64380-474-02 |
| ndc | 64380-475-01 |
| ndc | 64380-475-02 |
| ndc | 64380-476-01 |
| ndc | 64380-476-02 |
| ndc | 64380-477-01 |
| ndc | 64380-477-05 |
| ndc | 64380-478-01 |
| ndc | 64380-478-02 |
| code_info | Lot #: 25530722 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0538-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.