April 2026 FDA Recall Atomoxetine by Safecor Health, Llc
D-0538-2026 - Labeling
This Class II drug recall was voluntarily initiated by Safecor Health, Llc on April 30, 2026 for the product Atomoxetine. The FDA reported the reason for recall as labeling. The product was distributed in TX only and the recall is currently ongoing.
Recall Number: D-0538-2026
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
04-30-2026
05-27-2026
149 capsules
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX only
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 25530722
