DULOXETINE D/R recall
FDA recall D-0617-2026 · initiated Jun 22, 2026
Direct Rx recalled DULOXETINE D/R in Jun 2026 — an FDA Class II recall (D-0617-2026) 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: 263 Bottles
Details
- Product
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
- Recalling company
- Direct Rx
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Jun 22, 2026
- FDA report date
- Jul 1, 2026
Frequently asked
- Was DULOXETINE D/R recalled?
- Direct Rx recalled DULOXETINE D/R in Jun 2026 — an FDA Class II recall (D-0617-2026) 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 D/R recalled?
- Per the FDA enforcement record, the reason for recall D-0617-2026 was: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended 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: U.S. Nationwide. The recall covers these lots — Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.. 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-0617-2026.