FDAClass IIMay 8, 2024

Methylergonovine Maleate Tablets recall: Failed Dissolution

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

Why was Methylergonovine Maleate Tablets recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: BJ01922A, exp. date 03/2024

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 firm
Amneal Pharmaceuticals of New York, LLC
Quantity
2784 bottles
Distribution
US Nationwide.
Recall date
May 8, 2024
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls