Antidepressants Recalled Due to Impurity Contamination

Rising Pharma Holding, Inc. has issued a voluntary nationwide recall of multiple lots of duloxetine delayed-release (DR) capsules in various dosages. This recall encompasses over 360 000 bottles of the antidepressant, distributed in 30-count and 1000-count bottles, with varying expiration dates ranging from December 2024 to April 2025. The recall was initiated following the detection of N-nitroso-duloxetine impurities exceeding the recommended interim limits, a violation of Current Good Manufacturing Practices (CGMP). These impurities are classified as probable human carcinogens, heightening safety concerns.

The recall affects the following products:

• duloxetine delayed-release capsules, 30 mg, 30-count bottles (NDC 57237-018-30) and 1000-count bottles (NDC 57237-018-99), from lot DT3023051A (Exp. 4/25) and lot DT3023025A (Exp. 1/25);
• duloxetine delayed-release capsules, 20 mg, 60-count bottles (NDC 57237-017-60), from lots DT2023003A, DT2023007A, and DT2023008A (Exp. 1/25);
• duloxetine delayed-release capsules, 60 mg, 30-count bottles (NDC 57237-019-30) and 1000-count bottles (NDC 57237-019-99), from lots DT6023053A, DT6023061A, DT6023068A, and DT6023074A (Exp. 1/25); DT6023078A and DT6023076A (Exp. 2/25); DTC24043A and DTC24044A (Exp 12/25); DT6023002A, DT6023016A, and DT6023036A (Exp. 12/24); DT6023048A (Exp 1/25).

The US Food and Drug Administration (FDA) has classified this recall as Class II, indicating that exposure to the affected product may cause temporary or medically reversible adverse health effects, or that there is a remote probability of serious harm. The recall was formally initiated on December 30, 2024, with letters sent to impacted consignees. To date, no associated adverse events have been reported, but pharmacists and health care providers are urged to check their inventory and discontinue dispensing these products immediately.

Duloxetine is a prescription medication commonly prescribed for managing major depressive disorder (MDD), generalized anxiety disorder (GAD), and certain pain conditions, such as diabetic neuropathy. Patients currently prescribed duloxetine are advised to consult their health care providers to determine suitable alternatives while the recall is in effect. Rising Pharma has not released a public statement or press release but continues to work closely with the FDA to address the issue. Pharmacists are encouraged to monitor FDA updates for further guidance.