Gabapentin Prescription Capsules Recalled for Failed Impurity Specifications
Gabapentin 100-mg capsules are being recalled nationwide for out-of-specification impurity results from routine stability testing. Affected lot numbers expire between February 2026 and January 2027.
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 initiated following discovery of out-of-specification impurity during routine stability testing. The recall addresses a failed specification identified through quality control testing rather than reported field incidents or patient harm.
Plain-English summary
The Harvard Drug Group LLC is recalling Gabapentin Capsules (100 mg, USP) distributed nationwide. The recall affects specific lot numbers (M04989A, M05056A, M05150A, M05312A, M05342A) packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana, with expiration dates ranging from February 2026 to January 2027.
The recall was initiated following discovery of an out-of-specification result during routine stability testing. Testing identified a highest unknown impurity that exceeded acceptable limits.
Patients currently taking Gabapentin from affected lot numbers should contact their healthcare provider or pharmacist to determine whether their medication is involved in this recall. The affected lot number and expiration date can be verified on the prescription label.
Healthcare providers and pharmacists should quarantine all affected lots and consult with The Harvard Drug Group LLC or Major Pharmaceuticals regarding this recall.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Prescription / Oral
- Hazard
- impurity
- degradation
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.
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