Methylergonovine Maleate Tablet
FDA Recall NDC 0904-7282
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Methylergonovine Maleate (NDC 0904-7282). A significant event, classified as Class II, was initiated on Jun 16, 2026 by Major Pharmaceuticals. The reported reason for this action was: "Subpotent Drug"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Subpotent Drug
Jun 16, 2026
Jul 01, 2026
790 Cartons.
Recall Profile & Regulatory Data
Event ID
99240
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.
Affected Packages Involved in this Recall
0904-7282-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
