Recalls / Class II
Class IID-0383-2026
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.
- Brand name
- Midodrine Hydrochloride
- Generic name
- Midodrine Hydrochloride
- Active ingredient
- Midodrine Hydrochloride
- Route
- Oral
- NDCs
- 0904-6817, 0904-6818, 0904-6819
- FDA application
- ANDA077746
- Affected lot / code info
- Lot # N02640, Exp Date: 08/2027
Why it was recalled
Defective container; inadequately sealed blister packaging.
Recalling firm
- Firm
- The Harvard Drug Group LLC
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 8892 cartons
- Distribution pattern
- Nationwide US.
Timeline
- Recall initiated
- 2026-02-17
- FDA classified
- 2026-03-03
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0383-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.