Duloxetine Delayed-Release Capsules 60mg
Breckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.
Consult your healthcare provider or pharmacist regarding your medication. Do not stop taking your prescribed medication without first consulting a medical professional.
Why it was recalled
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules USP, 60mg, distributed nationwide. The recall is due to CGMP deviations and the presence of the impurity N-nitroso-duloxetine above the FDA recommended limit.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
- Recall #
- D-0522-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Breckenridge Pharmaceutical, Inc.
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification