FDA-Drug2026-07-01Class IICHEMICAL
Direct Rx Duloxetine D/R recalled for N-nitroso impurity above FDA limit
What this means
Direct Rx's packaged Duloxetine D/R 30 mg capsules contain levels of N-nitroso-duloxetine, a potentially harmful impurity, above FDA's recommended limit. This is a manufacturing quality issue affecting specific lots distributed nationwide.
- Check your Duloxetine D/R bottle for lot numbers 09JA2530, 31JA2507, 09DE2412, 09JA2528, or 29JA2511 (all expire 04/30/2027)
- Contact your pharmacist or doctor if you have one of the affected lots
- Do not stop taking your medication without talking to your doctor first
The agency's original wording
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
263 Bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2026Want us to check the next one for you?
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