Gabapentin Capsules 100 mg recalled for defective blister packaging
The Harvard Drug Group LLC is recalling 23,232 cartons of Gabapentin Capsules 100 mg (Lot# M05205, Exp Date 10/2026) distributed nationwide due to inadequately sealed blister packaging that may compromise product integrity.
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 or injuries. The hazard is a packaging defect (inadequate blister seal) that is a manufacturing or quality control issue rather than a high-risk contamination or safety hazard. This meets the criterion for Moderate severity.
Plain-English summary
The Harvard Drug Group LLC is recalling Gabapentin Capsules, USP, 100 mg, packaged in blister pack cartons (NDC 0904-6665-61 and related package NDCs), due to defective container sealing. The blister packaging has been found to be inadequately sealed.
The affected product is Lot# M05205 with an expiration date of 10/2026. Approximately 23,232 cartons were distributed nationwide by Major Pharmaceuticals, Indianapolis, IN.
Consumers who have received this product should not use it and should contact their pharmacist or physician for guidance on obtaining replacement product or alternative treatment options.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Prescription Capsule
- Affected units
- 23,232
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.
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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