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Class II · ModerateRecall completed

Gabapentin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot 1380040A, Exp. date July 31, 2025
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGranules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA foreign manufacturer
Brand nameGABAPENTIN
Generic nameGABAPENTIN
Active ingredient(s)GABAPENTIN
Distributed by / forGranules Pharmaceuticals Inc., Chantilly, VA
NDC70010-227-05
Show the full FDA record
Full product labelGabapentin 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
Recalling firmGranules Pharmaceuticals Inc.
DistributionNationwide in the USA
Quantity11,808 500-count Bottles
Recall initiated2024-07-31
Report date2024-08-14
Recall completed2025-06-12
Recall numberD-0634-2024
ClassificationClass II
FDA statusTerminated
Origin on fileChantilly VA United States

Related

Gabapentin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.