FDA Issues Class II Recall of Duloxetine Over Nitrosamine Impurity Risk
Key Insights
Nearly 375,000 bottles of duloxetine delayed-release capsules were voluntarily recalled by Towa Pharmaceutical and distributed by Breckenridge Pharmaceutical due to N-nitroso-duloxetine (search) levels exceeding FDA limits.
The impurity belongs to the nitrosamine class, some of which are probable human carcinogens; long-term exposure above acceptable levels may increase cancer risk.
The FDA classified the recall as Class II, indicating a remote probability of serious adverse health consequences or temporary, medically reversible effects.
Nearly 375,000 bottles of the widely prescribed antidepressant duloxetine have been voluntarily recalled after testing revealed the presence of a nitrosamine impurity at levels exceeding the U.S. Food and Drug Administration's recommended limits. The recall, initiated on June 4 by manufacturer Towa Pharmaceutical and distributor Breckenridge Pharmaceutical, Inc., was assigned a Class II risk classification by the FDA on June 8 — the agency's second-highest recall category.
The impurity, identified as N-nitroso-duloxetine (search), belongs to the nitrosamine class of chemical compounds. According to the FDA, exposure to nitrosamine impurities "may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time." The agency notes, however, that individuals exposed at or below the acceptable daily intake limit are not expected to have an increased risk of cancer. While there is no specific evidence directly linking N-nitroso-duloxetine to cancer, some nitrosamines are classified as probable human carcinogens.
Scope of the Recall
The recall encompasses two dosage strengths of duloxetine delayed-release capsules. The affected 30 mg formulation, packaged in 1,000-capsule bottles with lot code 241180C and an expiration date of April 2027, accounts for 14,729 bottles. The larger portion involves the 60 mg strength, totaling 359,676 bottles across multiple lot codes with expiration dates ranging from November 2026 through May 2027. The 60 mg capsules were distributed in both 90-capsule and 1,000-capsule bottle configurations.
Clinical Implications and Patient Guidance
A Class II recall, as defined by the FDA, indicates a situation in which "use of or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Health risks associated with nitrosamine exposure generally depend on both the amount and duration of exposure, with higher levels over longer periods posing greater concern.
Jennifer Young, PharmD, BCPS, CSP, lead medication safety specialist at the Institute for Safe Medication Practices, emphasized the importance of clinical guidance: "While recall notifications can be frightening, it's important to contact your healthcare provider right away for advice before making any changes to your medication routine." She added that "some medicines ... should not be stopped suddenly," underscoring the potential risks of abrupt discontinuation of antidepressant therapy.
Patients who identify their medication among the recalled lots are advised to contact their physician or pharmacist for a replacement and to discuss the most appropriate course of action. The FDA has not issued specific guidance suggesting that patients should independently discontinue treatment without medical consultation.