FDA recall D-0508-2025

The Harvard Drug Group LLC · Class II · drug

Product

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.

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-06-19
Report date: 2025-07-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0508-2025