Atomoxetine recalls: 15 FDA reports
Recalls involving Atomoxetine. What was wrong with each batch, and how the FDA graded the risk.
15Reports
0Class I
15Ongoing
2026-05-27Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only
D-0538-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- 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
- Where it went
- TX only
- How much
- 149 capsules
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc.
D-0236-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
- Where it went
- Nationwide within the U.S
- How much
- 87,600 bottles
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc.
D-0235-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
- Where it went
- Nationwide within the U.S
- How much
- 80,160 bottles
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, T
D-0239-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
- Where it went
- Nationwide within the U.S
- How much
- 119,040 bottles
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis,
D-0244-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
- Where it went
- Nationwide within the U.S
- How much
- 58,368 bottles
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc.
D-0231-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
- Where it went
- Nationwide within the U.S
- How much
- 70,032 bottles
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, T
D-0240-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
- Where it went
- Nationwide within the U.S
- How much
- 133,824 bottles
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc.
D-0232-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
- Where it went
- Nationwide within the U.S
- How much
- 56,208 bottles
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, T
D-0243-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
- Where it went
- Nationwide within the U.S
- How much
- 58,416 bottles
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc.
D-0233-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
- Where it went
- Nationwide within the U.S
- How much
- 175,920 bottles
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc
D-0237-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
- Where it went
- Nationwide within the U.S
- How much
- 39,168 bottles
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, T
D-0242-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
- Where it went
- Nationwide within the U.S
- How much
- 53,952 bottles
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc.
D-0234-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
- Where it went
- Nationwide within the U.S
- How much
- 190,320 bottles
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, T
D-0238-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
- Where it went
- Nationwide within the U.S
- How much
- 120,000 bottles
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, T
D-0241-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Product
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
- Where it went
- Nationwide within the U.S
- How much
- 233,040 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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