REGULATORY INTELLIGENCE·Recall
FDA Initiates Class II Recall for Major Pharmaceuticals' Gabapentin Due to Defective Blister Packaging
The FDA has classified a voluntary recall of Major Pharmaceuticals' Gabapentin Capsules, 100 mg, as Class II due to inadequately sealed blister packaging. This affects 23,232 cartons distributed nationwide, posing supply chain risks and necessitating immediate action from procurement and regulatory teams to ensure product integrity and patient safety.
90-Day Activity
Major PharmaceuticalsGabapentin
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2025-07-09