Warning
The Harvard Drug Group LLC Recalls Midodrine Hydrochloride Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0383-2026Drug / Pharmaceutical
The Harvard Drug Group LLC Recalls Midodrine Hydrochloride Tablets
The Harvard Drug Group LLC · Class II — Moderate Risk
Product Description
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.
Reason for Recall
Defective container; inadequately sealed blister packaging.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide US.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from The Harvard Drug Group LLC, initiated on February 17, 2026. Defective container; inadequately sealed blister packaging. This recall covers 8892 cartons, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.