Duloxetine Recall: Cymbalta 30 mg capsules (30 & 60 caps)
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027. |
|---|---|
| Lot / date codes | Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other duloxetine recalls
- Duloxetine Recall: Ajanta Pharma USA DR Capsules 30 mg · 2026-07-29
- Duloxetine Recall: Ajanta Pharma USA 60 mg capsules · 2026-07-01
- Duloxetine Recall: Breckenridge 3,591 bottles · 2026-06-17
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.