Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg, 10 capsules per blister pack, distributed nationwide in the United States. The recall cites failed impurities and degradation specifications from routine stability testing, specifically an out-of-spec Highest Unknown Impurity. Consumers and healthcare providers should stop using this product immediately and contact The Harvard Drug集团
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 a prescription medication used to treat nerve pain and seizures. This recall involves a 100 mg capsule sold in 10-count blister packs and distributed nationwide in the US.
A stability test identified an out-of-spec Highest Unknown Impurity, prompting the recall due to potential safety risk.
This recall is not described as part of a broader industry pattern in the notice.
The recall may disrupt treatment for patients currently using these lots. Patients must stop use and consult a healthcare provider for guidance.
FDA recall enforcement page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0031-2026
Recall does not specify refund/replacement timelines. Typically 4-8 weeks for processing disruptions may occur.
Keep the original packaging, lot number, expiration date, purchase receipts if available, and all correspondence with the provider or distributor.
Product: Gabapentin Capsules, USP, 100 mg, 10 capsules per blister pack. Rx only. Distributor: Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDCs: 0904-6665-61 (Blister pack), 55154-3363-0 (Outer Bag). Lot numbers: M04989A, M05056A, M05150A, M05312A, M05342A. Expiration dates: 02/2026, 04/2026, 07/2026, 01/2027. Sold nationwide in the US.
No injuries or incidents have been reported.
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