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Drug FDA Class II Ongoing Quality

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

The Harvard Drug Group LLC Published Jul 9, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact The Harvard Drug Group LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective container; blister packaging inadequately sealed.

Affected products (1)

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

GABAPENTIN · 23,232 cartons

NDC: 0904-6665, 0904-6666, 0904-6667, 0904-6665-61, 0904-6666-61, 0904-6667-61
Lot codes: M05205
Code info: Lot# M05205, Exp Date 10/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 19, 2025
  2. Published
    Jul 9, 2025
Recall number
D-0507-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.