FDA Recalls Over 233,000 Bottles of Duloxetine Over Cancer Risk
The U.S. Food and Drug Administration (FDA) has announced the recall of over 233,000 bottles of duloxetine, a common antidepressant, due to the presence of nitrosamine impurities—chemicals that can increase the risk of cancer when consumed in excessive amounts over extended periods.
Initially, the FDA recalled approximately 7,100 bottles of duloxetine in October. This expanded recall now includes capsules distributed nationwide by New Jersey-based Rising Pharmaceuticals, as reported by USA TODAY.
While the FDA classified this recall as Class II—indicating that the risk of severe health consequences is low—it still underscores the importance of addressing potential risks associated with these impurities.
Affected Duloxetine Products
The recall targets 30-count, 90-count, and 1000-count bottles containing duloxetine 60 mg capsules. The expanded list of lot numbers and expiration dates is detailed below:
30-Count Bottles:
- Lot numbers: DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A (Exp. Jan. 2025)
- DT6023080A (Exp. Feb. 2025)
- DT6023093A (Exp. Mar. 2025)
- DTC24012A (Exp. Dec. 2025)
90-Count Bottles:
- Lot numbers: DT6023108A (Exp. Apr. 2025), DTC23201A (Exp. Aug. 2025)
1000-Count Bottles:
- Lot numbers: DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A (Exp. Nov. 2024)
- DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B (Exp. Dec. 2024)
- DT6023067C (Exp. Jan. 2025)
- DT6023114A (Exp. Apr. 2025)
- DTC23243A (Exp. Oct. 2025), DTC24040A (Exp. Dec. 2025)
Understanding the Risk
The presence of nitrosamine impurities in duloxetine prompted the recall. According to the FDA, prolonged exposure to high levels of these impurities may increase cancer risk. However, consuming the chemical at acceptable levels daily for 70 years is not expected to pose a significant cancer risk.
What Should Patients Do?
If your medication is part of the recall, the FDA advises stopping its use immediately. Patients should consult their healthcare providers to explore alternative treatments.
For more information, visit the FDA’s recall page or contact your healthcare professional.
Key Takeaways:
- The recall includes over 233,000 bottles of duloxetine, following earlier recalls of smaller batches.
- Affected capsules contain nitrosamine impurities, classified as a potential carcinogen with long-term exposure.
- Patients are advised to discontinue use and consult their healthcare providers for guidance.
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