Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed b...
FDA Recall #D-0508-2025 — Class II — June 19, 2025
Product Description
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
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
3,527 bags
Distribution
Nationwide
Code Information
Lot# M05205A and M05205B, Exp Date 10/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated