D-0383-2026 Class II Ongoing
FDA drug recall D-0383-2026 was initiated by The Harvard Drug Group LLC on February 17, 2026 and is designated Class II. Reason for recall: Defective container; inadequately sealed blister packaging. The recall status is ongoing. Affected quantity: 8892 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- February 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8892 cartons
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.
Distribution Pattern
Nationwide US.
Code Information
Lot # N02640, Exp Date: 08/2027