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Class II · ModerateRecall completed

Methylergonovine Maleate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: BJ01922A, exp. date 03/2024
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals NY LLC
Brand nameMETHYLERGONOVINE MALEATE
Generic nameMETHYLERGONOVINE
Active ingredient(s)METHYLERGONOVINE MALEATE
Distributed by / forAmneal Pharmaceuticals, LLC, Bridgewater, NJ 08807
NDC69238-1605-2
Show the full FDA record
Full product labelMethylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionUS Nationwide.
Quantity2784 bottles
Recall initiated2024-03-25
Report date2024-05-08
Recall completed—
Recall numberD-0477-2024
ClassificationClass II
FDA statusCompleted
Origin on fileBrookhaven NY United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.