Reported Aug 14, 2024 · Terminated

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081,…

Granules Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Granules Pharmaceuticals Inc. · 3701 Concorde Pkwy · Chantilly, VA · 20151-1126

Is this the product you have?

  • Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only
  • Manufactured byGranules India Limited Hyderabad-500 081, India
  • Manufactured forGranules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
Lot codes and dates
    • Lot 1380040A
    • Exp. date July 31
    • 2025
Amount recalled
11,808 500-count Bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 12, 2025 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.