← FDA ENFORCEMENT
D-0477-2024Class II
Amneal Pharmaceuticals of New York, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product type
Drug
Status
Completed
Report date
2024-05-08
Distribution
US Nationwide.
Firm state
NY
Product quantity
2784 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Dissolution Specifications
Product description
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Code / lot info
Lot #: BJ01922A, exp. date 03/2024
Other recalls SPEQ maps to Validation & Qualification
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →