Duloxetine Delayed-Release Capsules USP 30 mg recall
FDA recall D-0188-2025 · initiated Dec 30, 2024
Rising Pharma Holding, Inc. recalled Duloxetine Delayed-Release Capsules USP 30 mg in Dec 2024 — an FDA Class II recall (D-0188-2025) 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: 42,527 bottles
Details
- Product
- Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Recalling company
- Rising Pharma Holding, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Dec 30, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was Duloxetine Delayed-Release Capsules USP 30 mg recalled?
- Rising Pharma Holding, Inc. recalled Duloxetine Delayed-Release Capsules USP 30 mg in Dec 2024 — an FDA Class II recall (D-0188-2025) 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 30 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0188-2025 was: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Is a recalled Duloxetine Delayed-Release Capsules USP 30 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 Delayed-Release Capsules USP 30 mg are affected?
- Distributed: Nationwide. The recall covers these lots — a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25. 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-0188-2025.