Nearly 370,000 bottles of duloxetine have been voluntarily recalled after tests found N-nitroso-duloxetine above the FDA's recommended interim limit. The impurity is considered a suspected carcinogen, though regulators say nitrosamines are common in food and only present a cancer risk with prolonged high exposure. The FDA has classified the recall as Class II. Affected lot codes have been published; patients should consult their pharmacist or prescriber and not stop medication abruptly.
Nearly 370,000 Bottles of Duloxetine Recalled Over Possible Carcinogenic Contamination
Stock image of medication on the shelf at the pharmacyCredit: Getty
Thousands of bottles of the antidepressant duloxetine have been voluntarily recalled after tests detected levels of an impurity that exceed the U.S. Food and Drug Administration's (FDA) recommended interim limit.
What Happened
Breckenridge Pharmaceutical, Inc. initiated the recall after laboratory samples indicated the "presence of N-nitroso-duloxetine impurity above FDA recommended interim limit," according to an FDA alert and reporting by Fox 8. N-nitroso-duloxetine is classified by the National Library of Medicine as a compound "suspected of causing cancer" and is described as "toxic if swallowed."
Stock image of bottles of DuloxetineCredit: Dhiraj Singh/Bloomberg via Getty
Scope Of The Recall
The voluntary recall affects nearly 370,000 bottles of duloxetine across multiple lot codes. Impacted lot codes include:
- 241074C
- 240317
- 240318
- 240315C
- 240373C
- 240370C
- 240375C
- 240413C
- 240316
- 232311
- 240978C
- 241052C
- 241180C
Risk And Regulatory Classification
The California State Board of Pharmacy notes that nitrosamines — a class of impurities that includes N-nitroso-duloxetine — are commonly found at low levels in foods and water. The board explains that a single exposure is unlikely to cause cancer, but long-term exposure to nitrosamines above acceptable limits may raise cancer risk.
Stock image of a woman reaching into her medicine cabinetCredit: Getty
Recall Class: This action is designated Class II by the FDA, meaning the product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is remote.
Previous Recall
This is the second duloxetine recall tied to potential nitrosamine contamination. In October 2024, more than 7,000 bottles were recalled for similar concerns.
About Duloxetine
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) commonly prescribed for major depressive disorder, generalized anxiety disorder, fibromyalgia, and diabetic peripheral neuropathy (nerve pain associated with diabetes).
What Patients Should Do
- If you have a bottle with one of the impacted lot codes, consult your pharmacist or prescribing clinician for guidance before making any changes to your medication.
- Do not stop taking duloxetine abruptly; sudden discontinuation can cause withdrawal symptoms. Any change should be supervised by a healthcare provider.
- Report suspected side effects or quality problems to the FDA’s MedWatch program and contact Breckenridge Pharmaceutical for information about returns or replacements.
PEOPLE has reached out to Breckenridge Pharmaceutical, Inc. for comment. Per the California State Board of Pharmacy, the distributor "was not aware of reports of adverse events that have been assessed to be related to this recall."
Note: This article summarizes public alerts and reporting; speak with a healthcare professional for personal medical advice.
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