Atomoxetine Capsules Recalled Due to Labeling Mix-Up Error
Safecor Health, LLC is recalling Atomoxetine HCl 10 mg capsules because some units are incorrectly labeled as 10 mg when they actually contain 25 mg. Patients taking the mislabeled product may receive an incorrect dose.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a significant dosing discrepancy (10 mg labeled vs. 25 mg actual), which presents a substantial risk of adverse health outcomes from overdose in a prescription medication used for attention disorders. The potential for serious harm from receiving 2.5 times the labeled dose justifies a Severe rating.
Plain-English summary
Safecor Health, LLC is recalling Atomoxetine HCl capsules due to a labeling mix-up. Atomoxetine HCl 25 mg capsules have been incorrectly labeled as Atomoxetine HCl 10 mg capsules.
The affected product is Atomoxetine Capsules HCl, 10 mg, in unit dose foil strip packaging (cartons of 100), Lot #25530722, NDC 64380-474-01, distributed in Texas only. The product was manufactured and packaged by Safecor Health, LLC in Columbus, Ohio.
Patients taking the mislabeled product may receive an incorrect dose. Any patient or healthcare provider who has this product should stop use and contact Safecor Health, LLC or their healthcare provider for guidance on replacement or proper dosing.
The recalled product
- Product
- ATOMOXETINE (ATOMOXETINE)
- Brand
- ATOMOXETINE
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Prescription / Capsule
- Hazard
- mis-labeling
- incorrect-dose
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 25530722
UPCs (7)
- 0364380477013
- 0364380475019
- 0364380478010
- 0364380474012
- 0364380472018
- 0364380476016
- 0364380473015
Distribution
Distributed in 1 state:
- TX