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.

Recall Insight

This FDA Drug action (record #D-0383-2026) was formally reported on March 11, 2026, with the manufacturer initiating the action on February 17, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. The Harvard Drug Group LLC is listed as the recalling firm, operating out of Dublin, OH. Federal records indicate 8892 cartons units are affected.

The documented reason for this recall is: Defective container; inadequately sealed blister packaging. Distribution data in the federal record shows the product reached: Nationwide US.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.