Up to 233,003 bottles of the prescription antidepressant duloxetine have been recalled across the US over fears of contamination with a potentially cancer-causing chemical.
The voluntary recall on November 19th, initiated by Emerging Medicineshas been classified as a Class II risk by the FDA, indicating potential health risks from exposure.
The recalled drugs have now been placed in a “Class II” risk level by the US Food and Drug Administration (FDA) because they “exist”. N-Nitroso-Duloxetine Contamination above the recommended provisional limit.”

What is a Class II recall?

The classification as Class II is considered the second highest value. This happens when “use or exposure to a harmful product may cause temporary or medically reversible adverse health effects, or when the likelihood of serious adverse health effects is low,” according to the FDA.
The FDA has issued a Class II recall for Costco butter that was missing the “Contains milk” statement. The FDA stated that use or contact with the butter may cause temporary or medically reversible adverse health effects. A Class III recall, on the other hand, is a situation in which use or exposure to a product is not expected to cause adverse health consequences.

What is Duloxetine?

According to the National Institutes of Health (NIH), duloxetine is a medication used to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), fibromyalgia, diabetic peripheral neuropathy, and chronic musculoskeletal pain. Off-label uses of duloxetine include chemotherapy-induced peripheral neuropathy and stress urinary incontinence.
According to a Newsweek report, the recalled products include the 30-count, 90-count and 1000-count bottles of 60 mg duloxetine capsules.
The recalled products of the 30 bottles include:
Lot numbers DT6023059A, DT6023060A, DT6023065A, DT6023069A and DT6023070A, with an expiration date of January 2025
Lot number DT6023080A with expiration date February 2025
Batch number DT6023093A with expiration date March 2025
Lot number DTC24012A with expiration date December 2025
90’s bottle products include:
Batch numbers DT6023108A with expiration date April 2025
Lot number DTC23201A with expiration date August 2025
1000 bottle products include:
Lot numbers DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A and DT6022173A, with expiration date November 2024
Lot numbers DT6023009A, DT6023007A, DT6023008A, DT6023011A and DT6023034B, with expiration date December 2024
Batch number DT6023067C with expiration date January 2025
Batch number DT6023114A with expiration date April 2025
Lot number DTC23243A with expiration date October 2025
Lot number DTC24040A with expiration date December 2025

What are N-nitroso compounds?

N-nitroso compounds are chemicals called nitrosamines. These are chemical contaminants that arise during the processing and production of certain foods such as bacon, cheese, sausages and fish. N-nitroso-duloxetine is a special type of N-nitroso compound that can be formed during the manufacturing or storage process of duloxetine.
Products containing N-nitroso-duloxetine impurities above the recommended interim limit are dangerous because they are classified as potentially carcinogenic.
Exposure to N-nitroso compounds beyond acceptable limits may pose long-term health risks.
In an earlier case, a batch of duloxetine manufactured by another company, Towa Pharmaceutical Europe, was recalled in October.
“There are several reasons why nitrosamines may be present in medicines. “The FDA has found that the source of the nitrosamines may be related to the drug’s manufacturing process or its chemical structure, or even to the conditions under which it is stored or packaged,” the FDA said in a statement at the time.
“Nitrosamines can also be formed when food and medicine are processed in the body. “The FDA continues to test and investigate possible sources of drugs found to contain nitrosamines.”