Midodrine Hydrochloride Tablets recall (The Harvard Drug Group LLC)
DrugClass IIOngoing
Summary: The Harvard Drug Group LLC is recalling 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: Defective container; inadequately sealed blister packaging.
What is being recalled
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.
Why
Defective container; inadequately sealed blister packaging.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide US.
How to tell if yours is affected
Lot # N02640, Exp Date: 08/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0383-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 17, 2026 |
| Reported | March 11, 2026 |
| Company | The Harvard Drug Group LLC |
| Company location | Dublin, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 8892 cartons |
More recalls from The Harvard Drug Group LLC · all drug recalls · recalls from February 2026