Gabapentin capsule bags recalled because blister packaging was inadequately sealed
Gabapentin Capsules 100 mg from Major Pharmaceuticals are being recalled because of a defective container: the blister packaging was inadequately sealed. 3,527 bags are affected.
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: FDA Class II recall over a packaging seal defect with no contamination or dosing error described in the source.
Plain-English summary
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, prescription only, packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana and distributed by Cardinal Health of Dublin, Ohio, NDC 55154-3363-0, are being recalled. The action covers 3,527 bags.
The stated reason is a defective container: the blister packaging was inadequately sealed. The FDA classified the action as Class II.
Affected lots are M05205A and M05205B, expiring 10/2026. Distribution was nationwide.
Patients and pharmacies holding affected lots should follow the instructions issued by the distributor. Anyone with questions about their prescription should speak to their pharmacist before stopping treatment.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Oral capsule
- Affected units
- 3,527
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.
Part of a larger recall action
This product is one of 2 recalled by The Harvard Drug Group LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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