Methylergonovine Maleate USP 0 — Class III drug recall D-1516-2019
Terminated recall by Amneal Pharmaceuticals, Inc., reported 2019-07-31, distributed nationwide. Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate
| Recall number | D-1516-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, Inc., Brookhaven, NY, United States |
| Recall initiated | 2019-07-18 |
| Classified | 2019-07-24 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-04-22 |
| Distributed | Nationwide (US) |
| NDC | 69238-1605-02, 69238-1605-08 |
| Lot numbers | BA10619A, BA10619B |
| Expiration dates | 2020-07 |
Product
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Reason for recall
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
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-1516-2019. 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.