Class IIOngoing

Gabapentin Capsules recall

FDA recall D-0031-2026 · initiated Oct 10, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Recalling company: The Harvard Drug Group LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Oct 10, 2025
FDA report date: Oct 29, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0031-2026 ↗

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