Why it was recalled
Defective container; inadequately sealed blister packaging.
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.
Lot numbers, UPCs & expiration codes
Lot # N02640, Exp Date: 08/2027
Where it was sold
Nationwide US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0383-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 17, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- 8892 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC
Original FDA data
Every field from FDA enforcement report D-0383-2026, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 98456
- Address
- 7000 Cardinal Pl
- Code information
- Lot # N02640, Exp Date: 08/2027
- Postal code
- 43017-1091
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0383-2026
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC
- Product quantity
- 8892 cartons
- Reason for recall
- Defective container; inadequately sealed blister packaging.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide US.
- Recall initiation date
- Feb 17, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2026