FDA recall D-0383-2026

The Harvard Drug Group LLC · Class II · drug

Product

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.

Distribution

Nationwide US.

Key facts

Status: Ongoing
Initiation date: 2026-02-17
Report date: 2026-03-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0383-2026