Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged ...

FDA Recall #D-0383-2026 — Class II — February 17, 2026

Recall #D-0383-2026 Date: February 17, 2026 Classification: Class II Status: Ongoing

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.

Reason for Recall

Defective container; inadequately sealed blister packaging.

Recalling Firm

The Harvard Drug Group LLC — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

8892 cartons

Distribution

Nationwide US.

Code Information

Lot # N02640, Exp Date: 08/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated