Duloxetine D/R recall
FDA recall D-0568-2025 · initiated Mar 7, 2025
Direct Rx recalled Duloxetine D/R in Mar 2025 — an FDA Class II recall (D-0568-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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: 875 bottles
Details
- Product
- Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
- Recalling company
- Direct Rx
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Mar 7, 2025
- FDA report date
- Aug 13, 2025
Frequently asked
- Was Duloxetine D/R recalled?
- Direct Rx recalled Duloxetine D/R in Mar 2025 — an FDA Class II recall (D-0568-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine D/R recalled?
- Per the FDA enforcement record, the reason for recall D-0568-2025 was: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Is a recalled Duloxetine D/R 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 D/R are affected?
- Distributed: Nationwide. The recall covers these lots — Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU…. 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-0568-2025.