Popular drug recalled over 'high levels' of cancer causing substance

A commonly-used antidepressant has been slapped with an urgent recall notice after testing found that certain batches of the drug may contain high levels of a cancer-causing compound.

Cymbalta, or Duloxetine, is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Basically, Duloxetine amends certain chemicals in the brain that may be unbalanced in people that suffer from depression. The medication is also used to treat general anxiety disorder in adults and children, and can be used to treat nerve pain in adults caused by diabetes (diabetic neuropathy), or chronic muscle, joint pain, osteoarthritis pain, and fibromyalgia.

As per a report by the US Food and Drug Administration (FDA), when tested the drug was found to contain levels of N-nitroso-duloxetine that were beyond the maximum FDA limit.

N-nitroso-duloxetine is a compound belongs to a class of organic chemical compounds that are classified as probable human carcinogens.

Essentially, that means that exposure to nitrosamines above acceptable dosages over long periods of time – say, if it were present in medication designed for long term use such as antidepressents – there is an increased risk of cancer as nitrosamines can cause cellular damage.

As a result, Breckenridge Pharmaceuticals has now recalled specific lots its duloxetine delayed-release capsules that were distributed throughiut the United States. The drug does not appear to have been sold abroad in the United Kingdom.

The recall applies to 30mg capsules of Cymbalta or Duloxetine distrubuted by Breckenridge Pharmaceuticals which have an expiration date of April 2027 and stem from Lot code 241180C, as per the FDA.

Breckenridge has issued further recalls for two lots of 60mg capsules, according to a separate notice published by the California Board of Pharmacy. The drugs carry expiry dates of February 2026 with the lot number 230286C and February 2027 with the lot number 24072lC.

Patients that have any of the recalled medications are advised to contact their doctor or pharmacist for advice on next steps. Patients are advised that they should not stop abruptly taking the medication without speaking to their doctor first.