D-0507-2025 Class II Ongoing

Recalled by The Harvard Drug Group LLC — Dublin, OH

FDA drug recall D-0507-2025 was initiated by The Harvard Drug Group LLC on June 19, 2025 and is designated Class II. Reason for recall: Defective container; blister packaging inadequately sealed. The recall status is ongoing. Affected quantity: 23,232 cartons.

Recall Details

Product Type
Drugs
Report Date
July 9, 2025
Initiation Date
June 19, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,232 cartons

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.

Distribution Pattern

Nationwide

Code Information

Lot# M05205, Exp Date 10/2026