MIDODRINE HYDROCHLORIDE
Recalling Firm / Manufacturer: The Harvard Drug Group LLC
(Dublin, OH, United States)
FDA Recall Number: D-0383-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
MIDODRINE HYDROCHLORIDE
Generic Name
MIDODRINE HYDROCHLORIDE
Active Substance(s)
Midodrine Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
0904-6817
Total Quantity Recalled
8892 cartons
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Defective container; inadequately sealed blister packaging.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 11, 2026
Firm Initiation Date
February 17, 2026
FDA Classification Date
Mar 03, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # N02640, Exp Date: 08/2027
Distribution Information
Geographic scope of affected shipments
Nationwide US.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0383-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC