On October 25, 2024, the U.S. Food and Drug Administration (FDA) issued a national recall of over 7,000 bottles of duloxetine. The recall was initiated after fears that the drug could be contaminated with a potentially cancer-causing agent known as a nitrosamine impurity. This recall impacts 7,107 bottles from the affected lot number 220128, with an expiration date of December 2024. Each bottle of Delayed-Release Amino Acid Capsules contains 500 capsules, each capsule providing a 20mg dosage.
Duloxetine, marketed as Cymbalta, is primarily prescribed to treat depression and anxiety. This recall is of grave concern to patients, on whom this medication is crucial to their mental wellbeing. The FDA has provided information regarding impurities in medications, including duloxetine, on its dedicated webpage titled “Information about Nitrosamine Impurities in Medications.”
Nitrosamine impurities are substances that may increase the risk of cancer if individuals are exposed to them above acceptable levels over extended periods. The FDA states that “a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.” As it stands, patients should consider the risk of not being on an indicated medication, when compared to the possible exposure risk.
At the FDA’s urging, continuity of medication is critical for individuals impacted by this recall. They write on their website that discontinuing their drug would result in serious dangers. These risks could outweigh the potential harms of nitrosamine exposure.
If you have received bottles from the impacted lot, please talk to your health care provider. Perhaps with your help, they can get you over any humps that you’ve got. According to the FDA, the impurity may cause serious temporary or medically reversible adverse health consequences. They think the likelihood of suffering serious negative impacts is exceedingly small.
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