Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Failed Dissolution Specifications
Class IIReported completed
Distribution: US Nationwide.
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0 reported ongoing
11 records in this archive. Latest source date Mar 25, 2024.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Failed Dissolution Specifications
Class IIReported completed
Distribution: US Nationwide.
Superpotent Drug: Due to overfilling of drug powder
Class IReported terminated
Distribution: Nationwide in the USA.
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class IIReported terminated
Distribution: Nationwide in the USA
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class IIReported terminated
Distribution: USA nationwide.
Failed dissolution specifications
Class IIReported terminated
Distribution: Product was distributed nationwide.
Failed Dissolution Specifications
Class IIReported terminated
Distribution: Nationwide in the USA and Puerto Rico
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class IIReported terminated
Distribution: LA, PA and OH.
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class IIIReported terminated
Distribution: Nationwide in the USA and PR
Failed dissolution specifications.
Class IIReported terminated
Distribution: USA nationwide
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class IIReported terminated
Distribution: Product was distributed nationwide within the United States
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class IIReported terminated
Distribution: Product was distributed nationwide within the United States
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 11 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.