The Recall Desk
ModerateFDA (Drugs)·D-0508-2025·Announced 2025-07-09

Prescription Gabapentin Capsules Recalled for Defective Blister Packaging

The Harvard Drug Group LLC is recalling Gabapentin Capsules due to inadequately sealed blister packaging. Patients should contact their pharmacy or healthcare provider regarding affected lots M05205A and M05205B.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The defect is a packaging integrity issue with no documented patient harm, fitting the Moderate category for precautionary pharmaceutical recalls.

Plain-English summary

The Harvard Drug Group LLC is recalling Gabapentin Capsules, USP, 100 mg due to defective containers with inadequately sealed blister packaging.

The recall includes 3,527 bags with lot numbers M05205A and M05205B, expiring October 2026. The affected product was packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana, and distributed by Cardinal Health. Distribution was nationwide.

Patients taking this recalled medication should contact their pharmacy or healthcare provider. Do not use the recalled product. Return unused medication to the pharmacy for proper disposal.

The recalled product

Product
GABAPENTIN (GABAPENTIN)
Brand
GABAPENTIN
Manufacturer
The Harvard Drug Group LLC
Category
Drug
Hazard
  • packaging-defect
  • seal-integrity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

UPCs (2)

  • 0055154336307
  • 0055154799201

Distribution

Distributed nationwide across the United States.