The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pha…
- Recall date
- October 10, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0030-2026
- FDA classification
- Class II
- Brand / firm
- The Harvard Drug Group LLC
- Sold / distributed
- US Nationwide.
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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