Atomoxetine Capsules recall
FDA recall D-0233-2025 · initiated Jan 29, 2025
Glenmark Pharmaceuticals Inc., USA recalled Atomoxetine Capsules in Jan 2025 — an FDA Class II recall (D-0233-2025) because CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 175,920 bottles
Details
- 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.
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Jan 29, 2025
- FDA report date
- Feb 26, 2025
Frequently asked
- Was Atomoxetine Capsules recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Atomoxetine Capsules in Jan 2025 — an FDA Class II recall (D-0233-2025) because CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Atomoxetine Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0233-2025 was: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Is a recalled Atomoxetine Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Atomoxetine Capsules are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0233-2025.