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D-0507-2025Class II

The Harvard Drug Group LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
The Harvard Drug Group LLC
Product type
Drug
Status
Ongoing
Report date
2025-07-09
Distribution
Nationwide
Firm state
OH
Product quantity
23,232 cartons
Initiated by
Voluntary: Firm initiated
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

Code / lot info

Lot# M05205, Exp Date 10/2026

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →