Duloxetine Delayed-Release Capsules USP recall
FDA recall D-0106-2025 · initiated Nov 19, 2024
Rising Pharma Holding, Inc. recalled Duloxetine Delayed-Release Capsules USP in Nov 2024 — an FDA Class II recall (D-0106-2025) 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: 122,925 bottles
Details
- Product
- Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, 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 Delayed-Release Capsules USP recalled?
- Rising Pharma Holding, Inc. recalled Duloxetine Delayed-Release Capsules USP in Nov 2024 — an FDA Class II recall (D-0106-2025) 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 Delayed-Release Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0106-2025 was: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Is a recalled Duloxetine Delayed-Release Capsules USP 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 USP are affected?
- Distributed: Nationwide.. The recall covers these lots — a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT…. 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-0106-2025.