Duloxetine Delayed-Release Capsules recall
FDA recall D-0009-2025 · initiated Oct 10, 2024
Breckenridge Pharmaceutical, Inc recalled Duloxetine Delayed-Release Capsules in Oct 2024 — an FDA Class II recall (D-0009-2025) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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: 7,107 bottles
Details
- Product
- Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
- Recalling company
- Breckenridge
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Oct 10, 2024
- FDA report date
- Oct 23, 2024
Frequently asked
- Was Duloxetine Delayed-Release Capsules recalled?
- Breckenridge Pharmaceutical, Inc recalled Duloxetine Delayed-Release Capsules in Oct 2024 — an FDA Class II recall (D-0009-2025) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine Delayed-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0009-2025 was: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Is a recalled Duloxetine Delayed-Release 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 Duloxetine Delayed-Release Capsules are affected?
- Distributed: Product was distributed nationwide within the United States. The recall covers these lots — Lot #: 220128, Exp. Date 12/2024. 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-0009-2025.