Class II · ModerateRecall completed
Gabapentin Tablets
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
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- 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
| Distributed by / for | Granules Pharmaceuticals Inc., Chantilly, VA |
| NDC | 70010-227-05 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Granules Pharmaceuticals Inc. |
| Distribution | Nationwide in the USA |
| Quantity | 11,808 500-count Bottles |
| Recall initiated | 2024-07-31 |
| Report date | 2024-08-14 |
| Recall completed | 2025-06-12 |
| Recall number | D-0634-2024 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Chantilly VA United States |
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.