PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: July 9, 2025 Initiated: June 19, 2025 #D-0507-2025

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.

Details

Units Affected
23,232 cartons
Distribution
Nationwide
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by The Harvard Drug Group LLC. Units affected: 23,232 cartons.
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-0507-2025.