Multiple lots of generic Cymbalta recalled after tests detect elevated nitrosamine levels
The U.S. Food and Drug Administration has issued a Class II recall for several lots of duloxetine delayed‑release capsules, a commonly prescribed antidepressant and anxiety medication, after testing identified elevated levels of N‑nitroso‑duloxetine, a nitrosamine impurity that exceeds federal safety limits.
The recall, initiated by Towa Pharmaceutical and distributed in the United States by Breckenridge Pharmaceutical, includes 30 mg and 60 mg capsules packaged in 90‑count and 1,000‑count bottles. According to FDA enforcement records, the affected lots were distributed nationwide, meaning pharmacies in North Carolina and South Carolina may have received the recalled product.
Nitrosamines are considered probable human carcinogens when exposure is above acceptable daily intake levels over long periods. The FDA notes that short‑term risk is low, but the impurity level requires removal of the affected lots from the market.
Patients currently taking duloxetine are advised not to stop the medication abruptly, as sudden discontinuation can cause significant withdrawal symptoms.
The FDA recommends that patients contact their pharmacy to determine whether their prescription is part of the recall and consult their healthcare provider before making any changes to treatment.
The recall remains active as distributors and pharmacies continue removing affected inventory from circulation.
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