Duloxetine Delayed-Release Capsules USP recall
FDA recall D-0212-2025 · initiated Jan 13, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Duloxetine Delayed-Release Capsules USP in Jan 2025 — an FDA Class II recall (D-0212-2025) because CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended 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: a) 6408 boxes and b)1488 boxes
Details
- Product
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jan 13, 2025
- FDA report date
- Feb 5, 2025
Frequently asked
- Was Duloxetine Delayed-Release Capsules USP recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Duloxetine Delayed-Release Capsules USP in Jan 2025 — an FDA Class II recall (D-0212-2025) because CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake 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-0212-2025 was: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake 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 within the United States. The recall covers these lots — Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025. 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-0212-2025.