← FDA ENFORCEMENT
D-0508-2025Class II

The Harvard Drug Group LLC

Recalling firm
The Harvard Drug Group LLC
Product type
Drug
Status
Ongoing
Report date
2025-07-09
Distribution
Nationwide
Firm state
OH
Product quantity
3,527 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Defective container; blister packaging inadequately sealed.

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

Code / lot info

Lot# M05205A and M05205B, Exp Date 10/2026.

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Data: U.S. FDA openFDA enforcement API. 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.