October 24, 2024

The FDA has announced a recall of over 7,000 bottles of duloxetine, marketed as Cymbalta, due to the presence of a potentially cancer-causing chemical, N-nitroso-duloxetine. Produced by Towa Pharmaceutical Europe, the affected lot (220128) includes 500-count, 20 mg delayed-release capsules and has a 12/2024 expiration date.

Experts advise against abruptly stopping the medication, as this could lead to withdrawal symptoms or a return of underlying conditions. Instead, patients should consult their healthcare providers about alternative treatments. The recall, initiated on October 10, is classified as Class II, indicating that exposure may result in temporary or reversible health issues.

N-nitroso-duloxetine is an impurity linked to increased cancer risk, similar to concerns raised in previous medication recalls. The FDA is investigating the source of this contamination. If you are taking duloxetine, check if your prescription is affected, and seek guidance from your doctor.