DULOXETINE D/R recall (Direct Rx)
DrugClass IIOngoing
Summary: Direct Rx is recalling 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.. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
What is being recalled
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.
Why
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0617-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 22, 2026 |
| Reported | July 1, 2026 |
| Company | Direct Rx |
| Company location | Dawsonville, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 263 Bottles |
More recalls from Direct Rx · all drug recalls · recalls from June 2026