Midodrine Hydrochloride Tablet
FDA Recall NDC 0904-6819
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Midodrine Hydrochloride (NDC 0904-6819). A significant event, classified as Class II, was initiated on Feb 17, 2026 by Major Pharmaceuticals. The reported reason for this action was: "Defective container; inadequately sealed blister packaging."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
February 2026 Class II Recall: Defective container; inadequately sealed blister packaging.
Recall Number
Class II Ongoing
Defective container; inadequately sealed blister packaging.
Feb 17, 2026
Mar 11, 2026
8892 cartons
Recall Profile & Regulatory Data
Event ID
98456
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide US.
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.
Batch or Lot Expiration Information
Lot# N02640, Exp Date: 08/2027
Affected Packages Involved in this Recall
0904-6817-06Product
0904-6817-61Product
0904-6818-06Product
0904-6818-61Product
0904-6819-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
