MedCentralCancer-Causing Chemical Spurs Second, Bigger Recall of Duloxetine

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Rising Pharmaceuticals has issued a nationwide recall of 233,003 bottles of duloxetine delayed-release capsules after detecting elevated levels of N-nitroso-duloxetine, a potentially carcinogenic impurity. This Class II FDA risk-level recall follows a smaller October 2023 recall by Towa Pharmaceutical Europe for the same chemical concern. The recall affects multiple lot numbers of 60 mg capsules in 30-count, 90-count, and 1000-count bottles with expiration dates ranging from November 2024 to December 2025.

Key Points:

• The FDA categorized this as a Class II risk level, indicating potential temporary or medically reversible adverse health consequences, with remote probability of serious health impacts
• The recall encompasses specific lot numbers of 60 mg duloxetine delayed-release capsules across three bottle sizes: 30-count (8 lot numbers), 90-count (2 lot numbers), and 1000-count (19 lot numbers)
• N-nitroso-duloxetine, when present in higher concentrations over extended periods, may increase cancer risk, though the FDA permits low levels commonly found in water and food products
• This recall follows a smaller October recall by Towa Pharmaceutical Europe of 7,107 bottles for the same impurity issue

“There is no reason to stop prescribing duloxetine, as the benefits outweigh the risk posed by the impurity found in a specific lot of the product.”
– David Cosio, PhD, ABPP, Psychologist, Jesse Brown VA Medical Center in Chicago

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