FDA DrugsClass II
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), R...
Published: March 11, 2026Recall ID: D-0383-2026Category: drugsCountry: US
Reason for Recall / Hazard
Defective container; inadequately sealed blister packaging.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Openfda › Unii | 59JV96YTXV |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 993462 |
| Openfda › Rxcui › 2 | 993466 |
| Openfda › Rxcui › 3 | 993470 |
| Openfda › Spl id | ead857d5-e960-4309-83f4-d9537cd32b9f |
| Openfda › Brand name | MIDODRINE HYDROCHLORIDE |
| Openfda › Spl set id | 164dce3b-1927-497e-884a-a2c72958beb9 |
| Openfda › Package ndc › 1 | 0904-6817-06 |
| Openfda › Package ndc › 2 | 0904-6817-61 |
| Openfda › Package ndc › 3 | 0904-6818-06 |
| Openfda › Package ndc › 4 | 0904-6818-61 |
| Openfda › Package ndc › 5 | 0904-6819-07 |
| Openfda › Product ndc › 1 | 0904-6817 |
| Openfda › Product ndc › 2 | 0904-6818 |
| Openfda › Product ndc › 3 | 0904-6819 |
| Openfda › Generic name | MIDODRINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MIDODRINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA077746 |
| Openfda › Original packager product ndc › 1 | 60505-1320 |
| Openfda › Original packager product ndc › 2 | 60505-1321 |
| Openfda › Original packager product ndc › 3 | 60505-1325 |
| Event id | 98456 |
| Address 1 | 7000 Cardinal Pl |
| Address 2 | N/A |
| Code info | Lot # N02640, Exp Date: 08/2027 |
| Postal code | 43017-1091 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 8892 cartons |
| Reason for recall | Defective container; inadequately sealed blister packaging. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260217 |
| Initial firm notification | Letter |
| Center classification date | 20260303 |
Overview
- Recalling FirmThe Harvard Drug Group LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide US.