Breckenridge Pharmaceutical Inc. of New Jersey is recalling nearly 375,000 bottles of Duloxetine Delayed-Release Capsules — a widely prescribed generic form of the antidepressant Cymbalta — after testing found levels of N-nitroso-duloxetine, a nitrosamine chemical, exceeding the FDA’s acceptable daily intake limit. The recall was initiated June 8, 2026. No adverse events have been reported. The recall covers both the 30mg and 60mg dose forms and is classified as Class II by the FDA.
What’s Being Recalled?
Two dose strengths of Duloxetine Delayed-Release Capsules are included:
30mg capsules (NDC 51991-747-10): Lot 241180C, expiration April 2027, packaged in 1,000-capsule bottles. Approximately 14,729 bottles affected.
60mg capsules (NDC 51991-748-90 and NDC 51991-748-10): Multiple lots, packaged in both 90-count and 1,000-count bottles, with expiration dates ranging from November 2026 through May 2027. Approximately 359,676 bottles affected.
The lot number and NDC are printed on each bottle label. The medication was manufactured by Towa Pharmaceutical Europe S.L. in Martorelles, Spain, and distributed nationwide by Breckenridge Pharmaceutical. The full lot code list is available in the FDA’s enforcement report at fda.gov.
Why Was This Product Recalled?
The recalled capsules contain N-nitroso-duloxetine above the FDA’s acceptable daily intake limit. Nitrosamines are chemical compounds found naturally at low levels in food and water. At elevated concentrations over long periods of time, some nitrosamines are classified as probable human carcinogens. However, this specific compound has no direct evidence linking it to cancer in humans, and the FDA notes that people exposed at or below acceptable limits — even over a lifetime — are not expected to have an increased cancer risk. The concern here is chronic exposure above those limits. This is Breckenridge‘s fourteenth recall event for duloxetine due to nitrosamine impurities since 2024.
What Should You Do?
Do not stop taking duloxetine without first consulting your prescribing doctor or pharmacist — abruptly discontinuing this medication can cause significant withdrawal symptoms including dizziness, nausea, and irritability. Contact your pharmacy to check whether your bottles are from a recalled lot and to arrange a replacement prescription from an unaffected lot. Consumers who purchased duloxetine out-of-pocket may be eligible for reimbursement through the Breckenridge Future Refund Program, established as part of a class action settlement. Visit breckenridgepharma.com or contact Breckenridge for refund eligibility details. Report any concerns to the FDA’s MedWatch program at fda.gov/safety/medwatch.
