FDA DrugsClass II
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (...
Published: July 1, 2026Recall ID: D-0609-2026Category: drugsCountry: US
Reason for Recall / Hazard
Subpotent Drug
Product Description & Identification
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.
Affected Products
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Openfda › Unii | IR84JPZ1RK |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 996824 |
| Openfda › Spl id | 27b7ce37-49f0-451f-b574-393564cd9435 |
| Openfda › Brand name | METHYLERGONOVINE MALEATE |
| Openfda › Spl set id | c7f19e89-8b52-4033-9914-f3b41fe0790d |
| Openfda › Package ndc | 0904-7282-10 |
| Openfda › Product ndc | 0904-7282 |
| Openfda › Generic name | METHYLERGONOVINE MALEATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | METHYLERGONOVINE MALEATE |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA210424 |
| Openfda › Original packager product ndc | 70010-786 |
| Event id | 99240 |
| Address 1 | 7000 Cardinal Pl |
| Address 2 | N/A |
| Code info | Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027. |
| Postal code | 43017-1091 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 790 Cartons. |
| Reason for recall | Subpotent Drug |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260616 |
| Initial firm notification | Letter |
| Center classification date | 20260622 |
Overview
- Recalling FirmThe Harvard Drug Group LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide.