Pharmacy Learning NetworkDuloxetine Delayed-Release Capsules Recalled Due to CGMP Deviations

📋 Regulatory Action / Label Change

A voluntary Class II recall of duloxetine 60 mg (Lot 241069C) affects 165,761 bottles distributed nationally, requiring immediate quarantine and inventory removal. N-nitroso-duloxetine impurity levels exceed acceptable thresholds; the FDA classifies the risk as temporary or medically reversible, with low probability of serious adverse health consequences.

Professional Impact

• Lot 241069C (exp. May 31, 2027), distributed by Breckenridge Pharmaceutical, is the sole affected lot; no other duloxetine lots or strengths are named in this recall
• N-nitrosamine impurities at elevated concentrations trigger Class II classification, distinct from Class I (immediate hazard) or Class III (unlikely harm), setting the urgency threshold for patient communication
• 165,761 bottles in national distribution increases the likelihood that community and health-system pharmacies hold affected inventory; proactive lot verification is warranted before dispensing
• Prescribers have received a Breckenridge letter notice; no public press release was issued, meaning patient awareness is limited and pharmacist-initiated outreach carries additional weight

Action Items

• Verify current duloxetine 60 mg inventory against Lot 241069C immediately
• Quarantine and remove affected bottles from dispensing stock per FDA recall protocol
• Notify prescribers of affected patients to coordinate alternative supply or therapeutic bridging
• Document recall response in pharmacy records, including lot verification, quarantine date, and prescriber contact
• Monitor the FDA Enforcement Report database for additional lots or strength expansions