CLASS II ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report
Atomoxetine Capsules HCL in unit dose foil strip, strips recalled
Safecor Health is recalling Atomoxetine Capsules HCL in unit dose foil strip, strips are, distributed in Texas. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0538-2026
- FDA event ID
- 98885
- Recalling firm
- Safecor Health, Columbus, OH
- Brand
- Atomoxetine
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2026
- FDA classified
- 18 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Drug class
- ADHD Medication
Timeline
| 30 Apr 2026 | Recall initiated by company | |
| 18 May 2026 | Classified by FDA | +18 days |
| 27 May 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Product as listed by the FDA
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
Where it was distributed
TX only
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Which lots are affected?
Lot #: 25530722
Where was it sold?
TX only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Vitamin B-Complex, Vitamin C & Folic Acid Dietary recalled | Safecor Health | Particulate Matter | OH |
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| Drug | CLASS II | Morphine Sulfate 5 mg per Oral Syringe, Delivers:, Oral Solution recalled | Safecor Health | Packaging Defects | Nationwide |
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Other Atomoxetine recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 10 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 40 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 60 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Atomoxetine Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsAtomoxetine | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |