Duloxetine Recall: Cymbalta 30 mg capsules (30 & 60 caps)
Announced 2026-07-01 · FDA
The recall is due to CGMP deviations: presence of N-nitroso-duloxetine impurity above FDA interim limit. The affected product is Cymbalta duloxetine delayed-release capsules, 30 mg, distributed nationwide by Direct Rx; lot numbers 09JA2530, 31JA2507 and 09DE2412, 09JA2528, 29JA2511 expire 04/30/2027, with 263 bottles distributed.
| Brand | Direct Rx |
|---|---|
| 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. |
| Reason | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Severity | moderate |
| Units affected | 263 |
| Distribution | U.S. Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027. |
WHAT YOU SHOULD DO
- Stop using any recalled Duloxetine (Cymbalta) capsules and keep the bottle.
- Check your bottle’s lot number against the recalled lots and contact Direct Rx for return or disposal instructions.
- Consult your healthcare provider if you have questions or symptoms, and monitor FDA recall updates for further guidance.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.