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Class III · Lower riskRecall completed

Gabapentin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot: T04468, Exp 10/2024
Where it was soldUSA Nationwide
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

Product mixup: one foreign tablet found in product.

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 byMajor Pharmaceuticals
Brand nameGABAPENTIN
Generic nameGABAPENTIN
Active ingredient(s)GABAPENTIN
Distributed by / forAurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
NDC0904-6823-61
Show the full FDA record
Full product labelGabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
Recalling firmThe Harvard Drug Group
DistributionUSA Nationwide
Quantity3984 cartons
Recall initiated2023-04-24
Report date2023-05-17
Recall completed2024-04-30
Recall numberD-0570-2023
ClassificationClass III
FDA statusTerminated
Origin on fileLa Vergne TN United States

Related

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.