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Class II · ModerateActive recall

Gabapentin

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

Does this affect you?
Check your lot numberLot# M05205A and M05205B, Exp Date 10/2026.
Where it was soldNationwide
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

Defective container; blister packaging inadequately sealed.

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 byCardinal Health 107, LLC
Brand nameGABAPENTIN
Generic nameGABAPENTIN
Active ingredient(s)GABAPENTIN
Distributed by / forMAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017
NDC55154-3363-0
Show the full FDA record
Full product labelGabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Recalling firmThe Harvard Drug Group LLC
DistributionNationwide
Quantity3,527 bags
Recall initiated2025-06-19
Report date2025-07-09
Recall completed—
Recall numberD-0508-2025
ClassificationClass II
FDA statusOngoing
Origin on fileDublin OH United States

Related

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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.