DULoxetine DR USP recall
FDA recall D-0163-2025 · initiated Dec 4, 2024
PD-Rx Pharmaceuticals, Inc. recalled DULoxetine DR USP in Dec 2024 — an FDA Class II recall (D-0163-2025) because CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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: 70, 90-count bottles
Details
- Product
- DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
- Recalling company
- PD-Rx Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed within US: FL, MS, WI
- Initiated
- Dec 4, 2024
- FDA report date
- Jan 1, 2025
Frequently asked
- Was DULoxetine DR USP recalled?
- PD-Rx Pharmaceuticals, Inc. recalled DULoxetine DR USP in Dec 2024 — an FDA Class II recall (D-0163-2025) because CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was DULoxetine DR USP recalled?
- Per the FDA enforcement record, the reason for recall D-0163-2025 was: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
- Is a recalled DULoxetine DR 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 DR USP are affected?
- Distributed: Distributed within US: FL, MS, WI. The recall covers these lots — Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025. 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-0163-2025.