The prescription drug Cymbalta, known generically as duloxetine, is under recall for cancer-causing impurities that may have occurred naturally.
Over 200,000 Pain, Diabetes, and Mood Medications Recalled Due to Potential Cancer Link
Published on Jan. 02, 2025
You may not be familiar with all of the ingredients found in your medications, but increasingly, one toxic chemical is making headlines for turning up where it doesn’t belong. The U.S. Food and Drug Administration (FDA) has announced that over 230,000 units of duloxetine, distributed by various firms, are now under recall due to excessive levels of a cancer-causing agent.
Duloxetine, often marketed under the brand name Cymbalta, is a type of selective serotonin/norepinephrine reuptake inhibitor (SSNRI) and can be prescribed to treat a variety of health conditions. Though it is most commonly used to treat depression, anxiety, and other mood disorders, it is also sometimes prescribed to relieve the symptoms of chronic muscle pain and stiffness (fibromyalgia), and pain caused by nerve damage caused by diabetes, the Mayo Clinic notes.
Last week, the FDA updated its recall notice to say that the affected drugs have been designated a Class II recall. In the FDA’s three-tier system used to alert consumers to a recall’s risk level, this represents the middle tier and suggests that exposure to the drugs could cause temporary or medically reversible harm. However, exposure to these drugs is unlikely to cause severe harm or death.
Health authorities initiated the recall when batches of the drugs were found to fall short of Current Good Manufacturing Practices (CGMP), a set of regulations ensuring public safety through quality control. In particular, the duloxetine was discovered to contain N-nitroso-duloxetine impurities that exceed the recommended interim limit. N-nitroso-duloxetine, a type of N-nitroso compound, can develop naturally during the manufacturing or storage process.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” the FDA says. However, “a person taking a drug that contains nitrosamines at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” they note.
This is not the first time in recent memory that medications have been recalled due to nitrosamine impurities. A similar recall affecting Cymbalta occurred in November. Nitrosamines have also been the cause of recent recalls involving the heartburn drug Zantac, the hypertension drug Nebivolol, the diabetes drug Metformin, and the smoking cessation medication Chantix.
The most current recall affected Duloxetine Delayed-Release Capsules in 30-count, 60-count, and 90-count bottles, as well as blister-pack cards. The recalling firms, product lot numbers, and expiration dates are as follow:
- Amerisource Health Services, LLC of Columbus, OH
- Lot # DT3023029A, DT3023030A, DT6022166A, DT6023071A, Exp. date: February 28, 2025
- Lot # DT6023061B, Exp. date: January 31, 2025
- Lot #, Exp. date: November 30, 2024
- Breckenridge Pharmaceutical, Inc of Berlin, CT
- Lot # 222205C, 230077C, Exp. date: November 2025
- RemedyRepack, Inc. of Indiana, PA
- Lot # J0786744-061724, Exp.date: June 30, 2025
- Lot # B3002625-060524, Exp. date: October 31, 2025
- PD-Rx Pharmaceuticals, Inc. of Oklahoma City, OK
- Lot # I24E77, A24E49, Exp. date: April 30, 2025
- Lot # J23C50, J23C97, L23B39, L23E98, Exp. date: January 31, 2025
If you suddenly stop taking Cymbalta, you may experience withdrawal symptoms, which can include nausea, dizziness, headache, mood changes, tingling skin, and more. If you believe you have the affected drugs in your possession, it’s advised that you do not abruptly discontinue use of your medication. Instead, contact your doctor to secure an alternative prescription before making any changes to your medication plan.
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