FDA Drug recall D-0383-2026
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals,…
- FDA Drug
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals,… by The Harvard Drug Group, citing defective container; inadequately sealed blister packaging.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0383-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-17 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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.
Reason
Defective container; inadequately sealed blister packaging.
Identifiers
| ndc | 0904-6817-06 |
|---|---|
| ndc | 0904-6817-61 |
| ndc | 0904-6818-06 |
| ndc | 0904-6818-61 |
| ndc | 0904-6819-07 |
| code_info | Lot # N02640, Exp Date: 08/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0383-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.