Methylergonovine Maleate Tablets recall
FDA recall D-0477-2024 · initiated Mar 25, 2024
Amneal Pharmaceuticals of New York, LLC recalled Methylergonovine Maleate Tablets in Mar 2024 — an FDA Class II recall (D-0477-2024) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2784 bottles
Details
- Product
- Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
- Recalling company
- Amneal Pharmaceuticals of New York, LLC
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Mar 25, 2024
- FDA report date
- May 8, 2024
Frequently asked
- Was Methylergonovine Maleate Tablets recalled?
- Amneal Pharmaceuticals of New York, LLC recalled Methylergonovine Maleate Tablets in Mar 2024 — an FDA Class II recall (D-0477-2024) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Methylergonovine Maleate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0477-2024 was: Failed Dissolution Specifications
- Is a recalled Methylergonovine Maleate Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Methylergonovine Maleate Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot #: BJ01922A, exp. date 03/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0477-2024.