Duloxetine recall 2024: What you need to know

At Kolli Psychiatric Associates, we are deeply committed to prioritizing our patients’ well-being by staying informed about the latest developments in mental health care. Our team of expert psychiatrists takes pride in offering evidence-based treatments, staying on top of news and updates that impact patient care, and maintaining a compassionate approach tailored to each individual’s needs.

Why was Duloxetine recalled?

More than 233,000 bottles of duloxetine, a widely prescribed antidepressant often used to treat depression and anxiety, have been recalled due to contamination with N-nitroso-duloxetine, a nitrosamine impurity. Nitrosamines, classified as potential human carcinogens, can increase the risk of cancer when consumed above safe levels over time.

The U.S. Food and Drug Administration (FDA) classified the recall as a Class II risk—the agency’s second-highest risk level—indicating the potential for “temporary or medically reversible adverse health consequences.” The recall was initiated by Rising Pharmaceuticals, a New Jersey-based company, on November 19, after tests revealed levels of N-nitroso-duloxetine exceeding the FDA’s recommended interim limit. While nitrosamines can naturally occur in foods and water, elevated levels in medications raise serious safety concerns.

Despite the recall, it’s important for patients taking duloxetine to understand that the risk remains low. Abruptly stopping duloxetine can lead to withdrawal symptoms or worsening depression or anxiety. Patients should always consult their psychiatrist or another healthcare provider before making changes to their medication.

Understanding the Contamination Concerns

The recall involves specific lots of duloxetine found to contain levels of N-nitroso-duloxetine above the FDA’s acceptable daily intake limit. Long-term exposure to these elevated levels poses potential health risks, but short-term exposure is not considered dangerous.

Manufacturer’s Actions and Recall Details

Pharmaceutical companies, in coordination with the FDA, have issued a voluntary recall of affected lots to remove them from distribution and protect patients. Rising Pharmaceuticals has yet to make a public statement but is cooperating with the recall process.

The new duloxetine recall affects various doses and bottles of the medication. See below for the exact products recalled:

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles

Lot numbers DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, with an expiration date of Nov. 2024
Lot numbers DT2023001B, DT2023004A, DT2023005A, DT2023006A, with an expiration date of Jan. 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, 30 count bottles

Lot number DT3023019A, with an expiration date of Jan. 2025
Lot number DT3023050A, with an expiration date of Apr. 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, 90 count bottles

Lot number DT3023022A, with an expiration date of Jan. 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, 1,000 count bottles

Lot numbers DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, with an expiration date of Nov. 2024
Lot numbers DT3023001A, DT3023003A, with an expiration date of Dec. 2024
Lot numbers DT3023024A, DT3023020B, with an expiration date of Jan. 2025
Lot numbers DT3023027A, DT3023028A, with an expiration date of Feb. 2025
Lot number DT3023034A, with an expiration date of Mar. 2025
Lot number DT3023049A, with an expiration date of Apr. 2025
Lot number DT3023095A, with an expiration date of Jul. 2025

Duloxetine Delayed-Release Capsules USP, 60 mg, 30 count bottles

Lot numbers DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, with an expiration date of Jan. 2025
Lot number DT6023080A, with an expiration date of Feb. 2025
Lot number DT6023093A, with an expiration date of Mar. 2025
Lot number DTC24012A, with an expiration date of Dec. 2025

Duloxetine Delayed-Release Capsules USP, 60 mg, 90 count bottles

Lot number DT6023108A, with an expiration date of Apr. 2025
Lot number DTC23201A, with an expiration date of Aug. 2025

Duloxetine Delayed-Release Capsules USP, 60 mg, 1,000 count bottles

Lot numbers DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, with an expiration date of Nov. 2024
Lot numbers DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, with an expiration date of Dec. 2024
Lot number DT6023067C, with an expiration date of Jan. 2025
Lot number DT6023114A, with an expiration date of Apr. 2025
Lot number DTC23243A, with an expiration date of Oct. 2025
Lot number DTC24040A, with an expiration date of Dec. 2025

Next Steps for Patients

Check Your Medication

Look for the lot number on your prescription bottle or packaging and compare it to the recalled lot numbers provided. If you’re unsure how to locate the lot number, your pharmacist can assist.

Pharmacy Notifications

When a recall is issued, the FDA informs all pharmacies, and affected pharmacies are required to contact patients whose prescriptions are part of the recall. If you have not been contacted but are concerned, reach out to your pharmacy directly.

Stop Taking Recalled Medication

If your medication is part of the recall, the FDA and Rising Pharmaceuticals recommend discontinuing use. However, do not stop taking duloxetine abruptly without consulting a healthcare provider, as this can lead to withdrawal symptoms or worsening of your condition.

Obtain a Replacement Prescription

Contact your psychiatrist or prescribing doctor to discuss safe alternatives or obtain a new prescription for duloxetine from unaffected batches. Pharmacies have been instructed to stop distributing the recalled pills and will provide replacements where necessary.

Communicate with Your Healthcare Provider

Open communication with your psychiatrist or healthcare provider is essential. They can address concerns about the recall, provide guidance on safe alternatives, and ensure your treatment plan remains effective.

Monitor FDA Updates

The FDA continues to oversee the recall process and may provide further updates. Stay informed through FDA announcements and your healthcare provider.

Safe Alternatives to Duloxetine

Patients seeking alternatives to duloxetine can discuss other serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine (Effexor) or desvenlafaxine (Pristiq) with their psychiatrist. For those managing depression or anxiety, selective serotonin reuptake inhibitors (SSRIs) like sertraline (Zoloft) or escitalopram (Lexapro) may also be effective options.

If you’re concerned about your medication, Kolli Psychiatric Associates in NJ can provide guidance on safe alternatives and support during this transition.

Moving Forward with Confidence

The duloxetine recall emphasizes the importance of medication safety. Patients should have open discussions with their psychiatrists to explore safe alternatives and ensure their treatment plans remain effective. Prioritize your mental health and well-being by staying informed and proactive.

Personalized Mental Health Treatment in NJ with Dr. Kolli and Her Team

At Kolli Psychiatric Associates, we are dedicated to providing compassionate, evidence-based care tailored to the unique needs of each patient. Our team stays informed about the latest updates in mental health treatments and medication safety, ensuring that we deliver the highest standard of care. If you have concerns about duloxetine, are exploring alternative medications, or are seeking support for your depression or anxiety, please call us at 732-655-4568 to learn how we can help. We proudly serve patients in New Jersey, including local communities like Rumson, Fair Haven, Marlboro, and the surrounding areas. Visit us at one of our convenient office locations in Freehold and Red Bank for expert psychiatric care close to home.

Sources:

https://www.webmd.com/depression/news/20241024/duloxetine-recall-n-nitroso-duloxetine

https://www.accessdata.fda.gov/scripts/ires/?Product=211120

https://eu.usatoday.com/story/news/health/2024/12/12/duloxetine-recall-fda-risk/76948609007/

https://www.health.com/duloxetine-recall-fda-risk-8758574