Gabapentin blister packs recalled after unknown impurity exceeded specification
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg in 10-capsule blister packs after routine stability testing returned an out-of-specification result for highest unknown impurity.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 as a specification failure: the record cites an out-of-specification unknown impurity without naming it, describing a health consequence, or reporting injury.
Plain-English summary
Gabapentin Capsules, USP, 100 mg, in 10-capsule blister packs, packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana, are being recalled for failed impurities and degradation specifications.
An out-of-specification result was obtained during routine stability testing for highest unknown impurity.
The recall covers lots M04989A (bag) and M04989 (blister pack), expiring February 2026, and M05056A and M05056, carrying NDC 0904-6665-61 for the blister pack and NDC 55154-3363-0 for the outer bag. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the specification failure without naming the impurity or describing a health consequence, and reports no injuries. Gabapentin is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Anticonvulsant
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 (14)
- Lot # M04989A [Bag]
- M04989 [Blister Pack]
- Exp Date: 02/2026
- Lot # M05056A [Bag]
- M05056 [Blister Pack]
- Exp Date: 04/2026
- Lot # M05150A [Bag]
- M05150 [Blister Pack]
- Exp Date: 07/2026
- Lot # M05312A [Bag]
- M05312 [Blister Pack]
- and M05342A [Bag]
- M05342 [Blister Pack]
- Exp Date: 01/2027.
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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