FDAClass IIJuly 9, 2025

Gabapentin Capsules recall

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

Why was Gabapentin Capsules recalled?

Defective container; blister packaging inadequately sealed.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
The Harvard Drug Group LLC
Quantity
3,527 bags
Distribution
Nationwide
Recall date
July 9, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls