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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 149
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 (4)
- 0364380475019
- 0364380478010
- 0364380476016
- 0364380477013
Distribution
Distributed in 1 state:
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