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Drug FDA Class II Ongoing Quality

Midodrine 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.

The Harvard Drug Group LLC Published Mar 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact The Harvard Drug Group LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective container; inadequately sealed blister packaging.

Affected products (1)

Midodrine 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.

MIDODRINE HYDROCHLORIDE · 8892 cartons

NDC: 0904-6817, 0904-6818, 0904-6819, 0904-6817-06, 0904-6817-61, 0904-6818-06, 0904-6818-61, 0904-6819-07
Lot codes: N02640
Code info: Lot # N02640, Exp Date: 08/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 17, 2026
  2. Published
    Mar 11, 2026
Recall number
D-0383-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.