Drug FDA Class II Terminated Foreign material

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

Granules Pharmaceuticals Inc. Published Aug 14, 2024

Risk level

Class II

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

Severity score 55/100

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 Granules Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Metformin ER 500 mg tablets · primary

Affected products (1)

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

GABAPENTIN · 11,808 500-count Bottles

NDC: 70010-227, 70010-228, 70010-227-01, 70010-227-05, 70010-228-01, 70010-228-05

Lot codes: 1380040A

Code info: Lot 1380040A, Exp. date July 31, 2025

Affected areas

Nationwide

Timeline

Initiated

Jul 31, 2024
Published

Aug 14, 2024
Terminated

Jun 12, 2025

Recall number: D-0634-2024
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.