FDA-Drug2026-06-17Class IICHEMICAL
Breckenridge Duloxetine 60mg capsules recalled for high impurity levels
What this means
Breckenridge Pharmaceutical is recalling specific lots of Duloxetine Delayed-Release Capsules 60mg due to higher-than-acceptable levels of a chemical impurity called N-nitroso-duloxetine. This impurity was found during manufacturing quality checks. The recall affects about 360,000 bottles distributed nationwide.
- Check if your Duloxetine 60mg matches one of the recalled lot numbers listed in the FDA notice.
- Do not stop taking your medication without talking to your doctor or pharmacist first.
- Contact your pharmacy or doctor to see if your supply is affected and discuss next steps.
- Return recalled bottles to your pharmacy for a replacement or refund.
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
Nationwide within the United States
Affected count
359,676 bottles
Manufactured in
200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0583-2026Want us to check the next one for you?
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