Duloxetine DR Capsules USP 60 mg recall
FDA recall D-0107-2025 · initiated Nov 19, 2024
Rising Pharma Holding, Inc. recalled Duloxetine DR Capsules USP 60 mg in Nov 2024 — an FDA Class II recall (D-0107-2025) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above 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 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: 233,003 bottles
Details
- Product
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
- Recalling company
- Rising Pharma Holding, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide.
- Initiated
- Nov 19, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Duloxetine DR Capsules USP 60 mg recalled?
- Rising Pharma Holding, Inc. recalled Duloxetine DR Capsules USP 60 mg in Nov 2024 — an FDA Class II recall (D-0107-2025) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine DR Capsules USP 60 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0107-2025 was: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Is a recalled Duloxetine DR Capsules USP 60 mg 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 DR Capsules USP 60 mg are affected?
- Distributed: Nationwide.. The recall covers these lots — a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT602217…. 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-0107-2025.