Food, drugs, devices › Amneal Pharmaceuticals of New York, LLC

Drug recall: Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bri

FDA enforcement event 94286 · Class II · initiated 25 Mar 2024 · status Completed

DrugVoluntary: Firm initiated1 product recordBrookhaven, NY

Amneal Pharmaceuticals of New York, LLC (Brookhaven, NY) initiated this drug recall on 25 Mar 2024; FDA lists 1 product record under event 94286, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.

Status: Completed. Initiation: voluntary: firm initiated. Amneal Pharmaceuticals of New York, LLC has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY.

Reason for recall

"Failed Dissolution Specifications"

Distribution

"US Nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0477-2024	Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.	2784 bottles	Class II	Completed	8 May 2024

Context

71%of 2024 drug events are Class II319 events that year

1product record in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for Amneal Pharmaceuticals of New York, LLC

Initiated	Product (first record)	Type	Class	Records
21 Mar 2024	Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15	Drug	Class I	1
13 Feb 2024	Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceu	Drug	Class II	1
15 Jan 2024	Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pv	Drug	Class II	1
26 Dec 2023	Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pv	Drug	Class II	1
27 Oct 2023	Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater	Drug	Class II	1
30 May 2023	Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutical	Drug	Class II	1
8 May 2023	Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injecti	Drug	Class III	1
27 Jul 2022	Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal	Drug	Class II	1
4 Nov 2021	Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals	Drug	Class II	2
29 May 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal	Drug	Class II	12

All 14 events for Amneal Pharmaceuticals of New York, LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide."

Is the recall still ongoing?

FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.