Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Gabapentin Capsules Recalled by The Harvard Drug Group LLC Due to Failed Impurities/Degradation Specifications: an out of specification result...

Date: October 10, 2025
Company: The Harvard Drug Group LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group LLC directly.

Affected Products

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

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Harvard Drug Group LLC

The Harvard Drug Group LLC has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report