Over 200,000 bottles of the antidepressant duloxetine have been recalled due to higher-than-acceptable levels of N-nitroso-duloxetine, a cancer-causing compound.This recall comes afterover 7,000 bottles of the same antidepressantwere recalled in October.The Food and Drug Administration (FDA) classified this as a Class II recall, meaning the contamination may “cause temporary or medically reversible adverse health consequences,” with a remote risk of serious harm. This is the second-highest category of the FDA’s three recall classes.Long-term exposure to high levels of nitrosamine impurities, like N-nitroso-duloxetine, may increase cancer risk.The California Board of Pharmacy has a comprehensive list of recalled duloxetinehere.Recall Pulls 70 Generic Drugs From the Market—What to Do If Your Medication Is One of ThemHow Did the Drugs Get Contaminated?It remains unclear how the duloxetine antidepressants became contaminated. However, contamination could occur during manufacturing or storage. Improved testing methods that can detect even trace amounts of nitrosamine might explain why these carcinogens have been found in multiple products.Rising Pharmaceuticals, the company that issued the most recent duloxetine recall, did not respond to Verywell’s request for comment.Nitrosamines are found in the environment, including in water and certain foods. The FDA sets acceptable daily limits for nitrosamine exposure but notes that it’s impossible to avoid these compounds entirely. According to the agency, taking a daily medication with nitrosamines at or below the acceptable daily intake limits for 70 years does not increase cancer risk.“We should remember that we are exposed to compounds that may increase our risk for cancer daily, and that generally our body is equipped to handle small exposures,”Jamie Alan, RPh, PharmD, PhD, an associate professor of pharmacology and toxicology at Michigan State University, told Verywell in an email.Cumulative lifetime exposure is likely the most important factor for many cancer-causing chemicals, she added.Drugmakers may recall products if nitrosamine levels exceed set limits. Since 2018, recalls have been issued for a number of drugs, including metformin, valsartan, losartan, and nizatidine capsules.What Should You Do If You Take Duloxetine?Duloxetine belongs to the class of medications calledselective serotonin and norepinephrine reuptake inhibitors (SNRIs)that help increase levels of serotonin and norepinephrine in the brain. This drug treats anxiety, depression, and certain pain conditions.“There are certainly alternatives available. There are other SNRIs available, including venlafaxine (Effexor) and desvenlafaxine (Pristiq),” Alan said.The FDA advises consulting a healthcare provider before stopping duloxetine treatment.Abruptly stopping the medication can cause withdrawal symptoms, including nausea, anxiety, depression, pain, dizziness, nightmares, and headaches.If you’re concerned about the duloxetine recall, Alan said it’s best to discuss with your doctor whether you should switch medications, and “if so, ask them about how to safely manage the change in medication.”Cymbalta vs. Effexor: Which Should You Choose?What This Means For YouIf you take duloxetine, check whether your medication is part of the recent recallshere. Speak with your healthcare provider before stopping treatment, as abrupt discontinuation can cause withdrawal symptoms.
Over 200,000 bottles of the antidepressant duloxetine have been recalled due to higher-than-acceptable levels of N-nitroso-duloxetine, a cancer-causing compound.
This recall comes afterover 7,000 bottles of the same antidepressantwere recalled in October.
The Food and Drug Administration (FDA) classified this as a Class II recall, meaning the contamination may “cause temporary or medically reversible adverse health consequences,” with a remote risk of serious harm. This is the second-highest category of the FDA’s three recall classes.
Long-term exposure to high levels of nitrosamine impurities, like N-nitroso-duloxetine, may increase cancer risk.
The California Board of Pharmacy has a comprehensive list of recalled duloxetinehere.
Recall Pulls 70 Generic Drugs From the Market—What to Do If Your Medication Is One of Them
How Did the Drugs Get Contaminated?
It remains unclear how the duloxetine antidepressants became contaminated. However, contamination could occur during manufacturing or storage. Improved testing methods that can detect even trace amounts of nitrosamine might explain why these carcinogens have been found in multiple products.
Rising Pharmaceuticals, the company that issued the most recent duloxetine recall, did not respond to Verywell’s request for comment.
Nitrosamines are found in the environment, including in water and certain foods. The FDA sets acceptable daily limits for nitrosamine exposure but notes that it’s impossible to avoid these compounds entirely. According to the agency, taking a daily medication with nitrosamines at or below the acceptable daily intake limits for 70 years does not increase cancer risk.
“We should remember that we are exposed to compounds that may increase our risk for cancer daily, and that generally our body is equipped to handle small exposures,”Jamie Alan, RPh, PharmD, PhD, an associate professor of pharmacology and toxicology at Michigan State University, told Verywell in an email.
Cumulative lifetime exposure is likely the most important factor for many cancer-causing chemicals, she added.
Drugmakers may recall products if nitrosamine levels exceed set limits. Since 2018, recalls have been issued for a number of drugs, including metformin, valsartan, losartan, and nizatidine capsules.
What Should You Do If You Take Duloxetine?
Duloxetine belongs to the class of medications calledselective serotonin and norepinephrine reuptake inhibitors (SNRIs)that help increase levels of serotonin and norepinephrine in the brain. This drug treats anxiety, depression, and certain pain conditions.
“There are certainly alternatives available. There are other SNRIs available, including venlafaxine (Effexor) and desvenlafaxine (Pristiq),” Alan said.
The FDA advises consulting a healthcare provider before stopping duloxetine treatment.Abruptly stopping the medication can cause withdrawal symptoms, including nausea, anxiety, depression, pain, dizziness, nightmares, and headaches.
If you’re concerned about the duloxetine recall, Alan said it’s best to discuss with your doctor whether you should switch medications, and “if so, ask them about how to safely manage the change in medication.”
Cymbalta vs. Effexor: Which Should You Choose?
What This Means For YouIf you take duloxetine, check whether your medication is part of the recent recallshere. Speak with your healthcare provider before stopping treatment, as abrupt discontinuation can cause withdrawal symptoms.
What This Means For You
If you take duloxetine, check whether your medication is part of the recent recallshere. Speak with your healthcare provider before stopping treatment, as abrupt discontinuation can cause withdrawal symptoms.
5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
National Library of Medicine: PubChem.N-nitroso duloxetine.
Food and Drug Administration.Recalls background and definitions.
Food and Drug Administration.Information about nitrosamine impurities in medications.
MedlinePlus.Duloxetine.
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