Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged a...
FDA Recall #D-0507-2025 — Class II — June 19, 2025
Product Description
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
Reason for Recall
Defective container; blister packaging inadequately sealed.
Recalling Firm
The Harvard Drug Group LLC — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
23,232 cartons
Distribution
Nationwide
Code Information
Lot# M05205, Exp Date 10/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated