PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: July 9, 2025 Initiated: June 19, 2025 #D-0508-2025

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.

Details

Units Affected
3,527 bags
Distribution
Nationwide
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by The Harvard Drug Group LLC. Units affected: 3,527 bags.
Why was this product recalled?
Defective container; blister packaging inadequately sealed.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 9, 2025. Severity: Moderate. Recall number: D-0508-2025.