Major Pharmaceuticals recalled Gabapentin capsules, 100 mg, 100-count, distributed nationwide in the United States. The recall stems from an out-of-spec highest unknown impurity found during stability testing. Healthcare providers and patients should stop using the product and contact The Harvard Drug Group LLC for guidance.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance
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Gabapentin is used to treat nerve pain and seizures. This recall concerns a 100 mg capsule package containing 100 capsules (10 x 10 blister packs).
An unknown impurity detected during stability testing may pose health risks. The exact hazard from the impurity is not specified in the recall notice.
This recall is not described as part of a broader industry pattern.
Patients using this product should stop taking it and consult a healthcare provider. Pharmacies and clinics may need to substitute with alternative therapies as guided by clinicians.
NDC 0904-6665-61 on packaging; Lot numbers and Exp dates printed on blister packs; FDA recall page for D-0030-2026
Recall processing and replacement guidance will be provided by The Harvard Drug Group LLC. No specific refund timeline is published.
Retain the recall notice, bottle label, lot numbers, expiration dates, and all communications with the supplier or healthcare provider.
Product: Gabapentin Capsules, USP, 100 mg, 100 capsules (10 x 10 blister packs). Packaged by: Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDC: 0904-6665-61. Sold as: Rx only. Distribution: US nationwide. Brand: Gabapentin. Generic: GABAPENTIN. Lot and expiration data reflect active lots listed below. Observed lots and expirations include M04950 (Exp 01/2026), M04989, M04990 (Exp 02/2026), M05056 (Exp 04/2026), M05150 (Exp 07/2026), M05290 (Exp 11/2026), M05312, M05342, M05369 (Exp 02/2027), M05386 (Exp 02/2027).
No injuries or incidents have been reported.
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