FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled May 27, 2026

Atomoxetine Capsules HCL recall — Safecor Health, LLC

Hazard: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0538-2026
Brand
Safecor Health
Classification
Class II
Units affected
149 capsules
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Columbus, OH, United States
Firm address
4060 Business Park Dr Ste B, 43204-5047

Identifying details (verbatim from the notice)

Product codes / lots
Lot #: 25530722
Distribution
TX only
Firm notified the public via
E-Mail
FDA event ID
98885
Recall initiated
April 30, 2026
FDA classified
May 18, 2026
FDA report date
May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

Report a data error on this page