Methylergonovine Maleate Tablets — Class II drug recall D-0477-2024
Completed recall by Amneal Pharmaceuticals of New York, LLC, reported 2024-05-08, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0477-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2024-03-25 |
| Classified | 2024-04-29 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,784 bottles |
| Reason classes | specification failure |
| NDC | 69238-1605, 69238-1605-02, 69238-1605-08 |
| Lot numbers | BJ01922A |
| Expiration dates | 2024-03 |
Product
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Reason for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0477-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.