FDA DrugsClass II
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are pac...
Published: May 27, 2026Recall ID: D-0538-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Product Description & Identification
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
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
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| Openfda › Upc › 1 | 0364380475019 |
| Openfda › Upc › 2 | 0364380478010 |
| Openfda › Upc › 3 | 0364380476016 |
| Openfda › Upc › 4 | 0364380477013 |
| Openfda › Unii | 57WVB6I2W0 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 349591 |
| Openfda › Rxcui › 2 | 349592 |
| Openfda › Rxcui › 3 | 349593 |
| Openfda › Rxcui › 4 | 349594 |
| Openfda › Rxcui › 5 | 349595 |
| Openfda › Rxcui › 6 | 608139 |
| Openfda › Rxcui › 7 | 608143 |
| Openfda › Spl id | 94ef88bd-e176-4c16-9340-ae0168422053 |
| Openfda › Brand name | ATOMOXETINE |
| Openfda › Spl set id | 2614df7e-0b16-4b03-883e-141d4ec34b35 |
| Openfda › Package ndc › 1 | 64380-472-01 |
| Openfda › Package ndc › 2 | 64380-472-02 |
| Openfda › Package ndc › 3 | 64380-473-01 |
| Openfda › Package ndc › 4 | 64380-473-02 |
| Openfda › Package ndc › 5 | 64380-474-01 |
| Openfda › Package ndc › 6 | 64380-474-02 |
| Openfda › Package ndc › 7 | 64380-475-01 |
| Openfda › Package ndc › 8 | 64380-475-02 |
| Openfda › Package ndc › 9 | 64380-476-01 |
| Openfda › Package ndc › 10 | 64380-476-02 |
| Openfda › Package ndc › 11 | 64380-477-01 |
| Openfda › Package ndc › 12 | 64380-477-05 |
| Openfda › Package ndc › 13 | 64380-478-01 |
| Openfda › Package ndc › 14 | 64380-478-02 |
| Openfda › Product ndc › 1 | 64380-472 |
| Openfda › Product ndc › 2 | 64380-473 |
| Openfda › Product ndc › 3 | 64380-474 |
| Openfda › Product ndc › 4 | 64380-475 |
| Openfda › Product ndc › 5 | 64380-476 |
| Openfda › Product ndc › 6 | 64380-477 |
| Openfda › Product ndc › 7 | 64380-478 |
| Openfda › Generic name | ATOMOXETINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ATOMOXETINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Strides Pharma Science Limited |
| Openfda › Application number | ANDA079021 |
| Openfda › Is original packager | true |
| Event id | 98885 |
| Address 1 | 4060 Business Park Dr Ste B |
| Code info | Lot #: 25530722 |
| Postal code | 43204-5047 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 149 capsules |
| Reason for recall | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Initial firm notification | |
| Center classification date | 20260518 |
Overview
- Recalling FirmSafecor Health, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionTX only