Duloxetine Delayed-Release Cap USP 30mg recall
FDA recall D-0505-2024 · initiated May 10, 2024
Preferred Pharmaceuticals, Inc. recalled Duloxetine Delayed-Release Cap USP 30mg in May 2024 — an FDA Class II recall (D-0505-2024) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA 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 FDA 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: 66 bottles of 30 tablets
Details
- Product
- Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Recalling company
- Preferred Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product distributed to CA, FL, OK, KS and CT
- Initiated
- May 10, 2024
- FDA report date
- May 29, 2024
Frequently asked
- Was Duloxetine Delayed-Release Cap USP 30mg recalled?
- Preferred Pharmaceuticals, Inc. recalled Duloxetine Delayed-Release Cap USP 30mg in May 2024 — an FDA Class II recall (D-0505-2024) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine Delayed-Release Cap USP 30mg recalled?
- Per the FDA enforcement record, the reason for recall D-0505-2024 was: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Is a recalled Duloxetine Delayed-Release Cap USP 30mg 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 Cap USP 30mg are affected?
- Distributed: Product distributed to CA, FL, OK, KS and CT. The recall covers these lots — Lot #: J2022G, Exp: 01/01/2025. 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-0505-2024.