Gabapentin capsules recalled due to inadequately sealed blister packaging
The FDA is recalling Gabapentin 100 mg capsules distributed nationwide. The recall is due to defective blister packaging that is inadequately sealed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves inadequately sealed blister packaging for an oral medication, representing a risk-of-harm product where no injuries have been reported. FDA Class II classification supports this assessment.
Plain-English summary
The FDA is recalling Gabapentin 100 mg capsules, USP in blister packs. The product was manufactured by The Harvard Drug Group LLC and distributed by Major Pharmaceuticals nationwide.
The recall affects approximately 23,232 cartons of Lot M05205 (Expiration Date 10/2026, NDC 0904-6665-61). The reason for the recall is defective container packaging: the blister packaging is inadequately sealed.
Consumers with this product should contact their pharmacy or healthcare provider for guidance on replacement or proper disposal.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Oral Capsule
- Hazard
- defective-packaging
- inadequate-seal
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# M05205
- Exp Date 10/2026
Distribution
Distributed nationwide across the United States.
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