This commonly prescribed medication was also hit with a recall earlier this year...for the same possible cancer-causing connection.

More than 12,000 Bottles of a Popular Antidepressant Have Been Recalled Nationwide

Once more of a taboo topic, mental health and wellness has thankfully been more at the forefront of health discussions in recent years—which is especially important since nearly a quarter of American adults live with a mental illness, according to the National Institute of Mental Health.
Recent data from the National Center for Health Statistics lists depression is one of most common mental health issues in the U.S. Though treatment for depression may vary based on symptoms and severity, doctors often prescribe medications known as selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs), per NIH MedlinePlus Magazine. One common medication, however, is the subject of a new recall.
On Thursday, July 10, the U.S. Food and Drug Administration (FDA) alerted the public to the nationwide recall of 12,242 30-count bottles of Duloxetine Delayed-Release Capsules.
Duloxetine is a prescription medication that’s often used to treat depression and anxiety, as well as fibromyalgia and certain types of chronic nerve pain, says the Cleveland Clinic. The medication is also commonly referred to by the brand names Cymbalta, Drizalma, or Irenka.
The FDA report lists “CGMP Deviations” as the reason for the recall. This indicates that the medication did not meet Current Good Manufacturing Practice (CGMP) regulations, which help ensure that drugs “contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product,” per the FDA.
Elaborating on the CGMP deviation, the FDA points to the “presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. The agency has recommended nitrosamine intake limits due to “carcinogenic potency.” Carcinogenic substances can increase your cancer risk, according to the Cleveland Clinic.
The FDA shared the following identifying details about the recalled medication:
- 30-count bottles of Duloxetine Delayed-Release Capsules, USP, 40 milligrams (mg)
- Available by prescription only
- Manufactured by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain
- Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, New Jersey
- National Drug Code (NDC): 51991-750-33
- Lot number: 230199
- Expiration date: 01/31/2026
Earlier this year, both the listed manufacturer, Towa Pharmaceutical Europe, and listed distributor, Breckenridge Pharmaceuticals, Inc., were connected to another duloxetine recall for the same reported reason.
Though recall was evidently first initiated on June 30, it wasn’t until July 9 that the FDA labeled it as a Class II risk. A Class II recall involves “products that may cause temporary or medically reversible adverse health effects.”
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