More Than 165,000 Bottles of a Trusted Pain & Mood Drug Were Recalled Nationwide

A nationwide recall of one of the country’s most commonly prescribed medications treating depression, pain, and anxiety has come to a close more than a year after it was first executed. Yet product expiration dates set for this coming November and December—as well as a repeated pattern of offense—may serve as a reminder to stay vigilant even after the public has moved on from an incident. 

In May 2024, the U.S. Food and Drug Administration (FDA) announced that 165,678 90-count bottles of Duloxetine Delayed-Release Capsules in 60-milligram doses were under recall. The drugs were manufactured by Towa Pharmaceutical Europe, S.L. in Barcelona, Spain, and distributed by Breckenridge Pharmaceuticals, Inc., in Berkeley Heights, New Jersey.

Duloxetine is the generic form of the branded medications Cymbalta, Drizalma and Irenka. In addition to being used as an antidepressant and anti-anxiety medication, it is also used to treat “fibromyalgia and certain types of chronic pain such as nerve, bone or joint pain,” according to the Cleveland Clinic. 

Data in 2023 suggested 18 million Americans took Duloxetine, according to ClinCalc, a site that uses government data to track drug usage in the U.S. Belonging to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs), Duloxetine works by increasing those hormones to regulate your mood and pain levels, Cleveland Clinic experts note. 

The products were pulled from pharmacies when health authorities discovered that they contained N-nitroso-duloxetine impurities above the FDA’s recommended interim limit. This chemical, a type of nitrosamine compound, is considered a cancer risk in cases of long-term exposure, so finding too much of it in a drug—even in small amounts over the FDA’s limit—is considered a health concern.

If this particular story sounds familiar, it’s because over the last year, the chemical has repeatedly turned up in Duloxetine and other medications. In fact, Towa Pharmaceutical Europe and Breckenridge Pharmaceuticals have been named in several recent Duloxetine recalls, including one in July. In November 2024, the FDA recalled 233,003 bottles of the drug, distributed by Rising Pharmaceuticals, Inc., citing the same out-of-range impurity levels. Sparking a wider FDA investigation, nitrosamines have also turned up in medications used to treat high blood pressure, heart failure, heartburn, and more. 

In June 2024, the FDA assigned the 165,000-bottle incident a Class II risk level, representing the middle tier in a three-tier system used to communicate health risks to the public. The affected items bear the National Drug Code (NDC) 51991-748-90, and are printed with the following lot numbers and upcoming expiration dates:

• Lot #: 230035C, Exp. date 11/30/2025
• Lot #: 230101C, Exp. date 12/31/2025

Many medical experts emphasize the importance of speaking with your doctor or pharmacist before making any changes to your drug regimen. In cases of certain drugs, including those that impact mood, it is important not to stop taking your medication abruptly. Your doctor may prescribe an alternative in an effort to mitigate withdrawal effects.

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