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Antidepressant Recall: More Than 350,000 Bottles Pulled Over Potential Carcinogen Concern

The FDA says certain lots of duloxetine (the generic for Cymbalta) could be affected

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Key Takeaways

  • Over 350,000 bottles of antidepressant duloxetine (generic for Cymbalta) have been recalled.
  • The medication could contain levels of nitrosamines, a carcinogen, above the safe limit.
  • Do not to stop taking duloxetine suddenly—contact your healthcare provider first.

Recalls are always a little bit unsettling, but when they affect medication meant to improve your quality of life, it can leave consumers feeling uncertain, fearful and wary going forward. With that in mind, patients who have been prescribed the antidepressant duloxetine, the generic version of Cymbalta, are being warned to check their medicine cabinets as the popular drug has been recalled due to the presence of a potentially cancer-causing chemical. Here, all about the antidepressant recall. 

Antidepressant recall affects thousands of bottles

Earlier this month, the FDA announced a recall of duloxetine delayed-release capsules, a generic form of the antidepressant Cymbalta, manufactured by Towa Pharmaceuticals and distributed by Breckenridge Pharmaceutical, Inc. According to the report, this medication contains levels of N-nitroso-duloxetine, a nitrosamine, above the limit recommended by the FDA. 

What are nitrosamines?

Nitrosamines are carcinogenic chemical compounds, but many of us consume these compounds in small, non-harmful amounts in various medications. While the FDA has set guidelines for daily intake of nitrosamines, when they are consumed at higher levels than the recommended limit over a long period of time, cancer risk can increase.

According to the FDA, the ways in which nitrosamines come to be present in drugs varies. “FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As foods and drugs are processed in the body, nitrosamines can also be formed.”

Antidepressant recall: Check your medicine cabinet

 

Over 350,000 bottles of duloxetine have been recalled. Here’s how to check if your medication is affected:

30-mg duloxetine delayed-release capsules (1,000-count bottles):

  • Lot code: 241180C
  • Expiration date: April 2027
  • Bottles affected: 14,729

60-mg duloxetine delayed-release capsules (90-count and 1,000-count bottles):

  • Lot codes: 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C | Expiration: February 2027
  • Lot codes: 240978C, 241052C | Expiration: April 2027
  • Lot code: 232311 | Expiration: November 2026
  • Lot code: 240316 | Expiration: January 2027
  • Lot code: 241074C | Expiration: May 2027
  • Bottles affected: 359,676

What to do about the antidepressant recall

If your antidepressants have been affected by this recall, contact your doctor to determine the best course of action. The FDA classified this as a Class II recall, meaning there’s a potential for temporary or reversible health consequences. Avoid abruptly stopping the medication without first discussing the risks and benefits with your doctor.

This content is not a substitute for professional medical advice or diagnosis. Always consult your physician before pursuing any treatment plan.

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