Cancer Risk Prompts FDA Recall of Over 233,000 Antidepressant Bottles

U.S. Food and Drug Administration (FDA) has issued a recall for more than 233,000 bottles of duloxetine, due to the presence of nitrosamine impurities, a chemical associated with enhanced cancer risk when consumed beyond safe levels over prolonged time periods.

Duloxetine, an antidepressant, commonly prescribed for mental health conditions like anxiety and depression, was recalled after testing revealed levels of N-nitroso-duloxetine exceeding recommended limits. The recall, classified as Class II, the second most severe class, shows that the medication may affect temporary or medically reversible adverse health effects, even though the possibility of severe harm is minimal.

This marks the second duloxetine recall no.19 in 2024; a prior recall in October included 7,107 bottles supplied by Towa Pharmaceutical Europe for similar concerns. The current recall, announced in November, consists of 30-count, 90-count, and 1,000-count bottles manufactured by Rising Pharmaceuticals, with specific lot numbers and expiration dates presented by the FDA.

Lot numbers and expiration dates of recently recalled bottles:

Nitrosamines, which are naturally observed in water, meats, dairy products, and vegetables, can raise cancer risk if exposure is above acceptable levels. However, the FDA highlights that using nitrosamines at or below these levels daily for 70 years is not estimated to cause a cancer risk.

Recall bottles were supplied nationwide, including in Wisconsin, and have been removed from pharmacies. Patients presently taking the recalled medication are instructed to stop immediately and consult their physicians for alternate medications. Pharmacies have stopped supplying, and Rising Pharmaceuticals has announced a voluntary recall notice.

The FDA’s actions suggest broader concerns about nitrosamine contamination, which has also led to recalls of other medications such as valsartan, Zantac, metformin, and Chantix in current years. Patients involved in the recall should request advice on alternative treatments while checking further updates from the FDA.

References:

1. Anthony Robledo and Taylor Ardrey. FDA recalls more than 233,000 bottles of antidepressant over possible cancerous chemicals. USA Today. December 13, 2024. Accessed from https://www.usatoday.com/story/news/health/2024/12/12/duloxetine-recall-fda-risk/76948609007/
2. Chad Van Alstin. FDA recalls 233K bottles of antidepressants due to cancer risk. December 13, 2024. Accessed from https://healthexec.com/topics/healthcare-management/healthcare-logistics/fda-recalls-233k-bottles-antidepressants-due-cancer-risk
3. Maia Pandey, Milwaukee Journal Sentinel. FDA recalls more than 233,000 bottles of antidepressants for cancer risk. What to know. Yahoo News. December 13, 2024. Accessed from https://www.yahoo.com/news/fda-recalls-more-233-000-164757278.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAJPBBSq06AqlO2Cn3gpOexx_zOusltYumSfMsBJFuQx56r1roV8k2KFb_eClQogwLARHUUix5C7xXP5BpuzhsUzr4-9rKRRSUd0HxJPL-MGh9xYY4j9g5CSLWLGGUOXiUwBIugwqhqitnxXX77f07AkKnsKeobvkInVE2Fl0g42j
4. Food and Drug Administration (FDA). Recall Number: D-0107-2025. 2024. https://www.accessdata.fda.gov/scripts/ires/?Product=211120