FDA-Drug2026-06-17Class IICHEMICAL
Breckenridge Duloxetine 60mg capsules recalled for high impurity levels
HEAVY METALSNationwide distribution
Breckenridge Duloxetine 60mg recalled for impurity risk
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.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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-0583-2026More Breckenridge Pharmaceutical, Inc. recalls
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