Data Composite

Recall D-0030-2026

US Class II Ongoing · initiated 2025-10-10

Recalling firm

The Harvard Drug Group LLC, OH

Product

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

Reason for recall

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

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