The Harvard Drug Group LLC: Drug Recall

Recall #D-0507-2025 · 06/19/2025

Class II: Risk

Recall Details

Recall Number: D-0507-2025
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group LLC
Status: Ongoing
Date Initiated: 06/19/2025
Location: Dublin, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,232 cartons

Reason for Recall

Defective container; blister packaging inadequately sealed.

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

Distribution Pattern

Nationwide

Other Recalls by The Harvard Drug Group LLC

Class II: Risk 10/10/2025

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II: Risk 10/10/2025

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II: Risk 06/19/2025

Defective container; blister packaging inadequately sealed.

View all recalls by The Harvard Drug Group LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.