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Lower risk Drug recall · FDA · Published July 31, 2024

Granules Pharmaceuticals Recalls Gabapentin Tablets Due to Metformin Contamination

Granules Pharmaceuticals recalls 600mg Gabapentin tablets (500-count) with metformin tablets found inside. Consumers should check lot numbers and contact the company for details.

🇺🇸 FDA recall #D-0634-2024DrugGranules Pharmaceuticals ›
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Contact the company

Recalling firmGranules Pharmaceuticals Inc.3701 Concorde Pkwy · Chantilly, VA 20151-1126
✎ GovInfoNow plain-language explainer

What happened, in plain English

Granules Pharmaceuticals is recalling 600mg Gabapentin tablets (500-count bottles) because foreign metformin tablets were found inside. This could cause unintended medication interactions if taken. Read more at govinfonow.com/recall/32578-granules-pharmaceuticals-recalls-gabapentin-tablets-due-to-metformin-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/32578-granules-pharmaceuticals-recalls-gabapentin-tablets-due-to-metformin-contamination · Updated August 17, 2026 · FDA enforcement record: FDA #D-0634-2024

Cite this page

“Granules Pharmaceuticals Recalls Gabapentin Tablets Due to Metformin Contamination.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32578-granules-pharmaceuticals-recalls-gabapentin-tablets-due-to-metformin-contamination. Based on FDA recall #D-0634-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0634-2024%22&limit=1).

Why it’s dangerous

Foreign metformin tablets were found inside the gabapentin bottles. This could cause unintended medication interactions if someone takes both drugs without knowing.

Who’s affected

People who have the 600mg Gabapentin tablets (500-count) with lot number 1380040A manufactured in India. Those taking gabapentin for seizures or nerve pain are most at risk.

How to tell if you have this one

Check for the lot number 1380040A on the bottle. The product was manufactured in India by Granules India Limited and sold in the US by Granules Pharmaceuticals Inc.

  • Brand
    Granules Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 1380040A on the bottle label.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Jul 31, 202412. FDA classified it Class II: Aug 14, 202423. Published in FDA’s Enforcement Report: Aug 14, 202434. FDA terminated the recall: Jun 12, 2025420242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury?

The recall is for medication safety, not physical injury risk. No serious injury mechanism is described.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0634-2024 (July 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0634-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.