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Class II · ModerateActive recall

Midodrine Hydrochloride

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

Does this affect you?
Check your lot numberLot # N02640, Exp Date: 08/2027
Where it was soldNationwide US.
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; inadequately sealed blister packaging.

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 nameMIDODRINE HYDROCHLORIDE
Generic nameMIDODRINE HYDROCHLORIDE
Active ingredient(s)MIDODRINE HYDROCHLORIDE
Distributed by / forMajor Pharmaceuticals, Indianapolis, IN 46268 USA
NDC0904-6818-06
Show the full FDA record
Full product labelMidodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
Recalling firmThe Harvard Drug Group LLC
DistributionNationwide US.
Quantity8892 cartons
Recall initiated2026-02-17
Report date2026-03-11
Recall completed
Recall numberD-0383-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDublin OH 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.