--- title: "Amneal Pharmaceuticals of New York, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Amneal Pharmaceuticals of New York, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/amneal-pharmaceuticals-of-new-york-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Amneal Pharmaceuticals of New York, LLC recall records **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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Mar 25, 2024 FDA drug enforcement ### [Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.](https://isitonrecall.com/recall/fda-drug-d-0477-2024-methylergonovine-maleate-tablets-usp-0-2mg-12-count-bottle-rx-only-distributed-by-amneal-pharmaceuti/) Failed Dissolution Specifications Class II Reported completed Distribution: US Nationwide. [Official source for Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Ph...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0477-2024%22) Mar 21, 2024 FDA drug enforcement ### [Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 6923...](https://isitonrecall.com/recall/fda-drug-d-0442-2024-vancomycin-hydrochloride-for-oral-solution-usp-250-mg-per-5-ml-packaged-as-a-80-ml-bottle-ndc-69238/) Superpotent Drug: Due to overfilling of drug powder Class I Reported terminated Distribution: Nationwide in the USA. [Official source for Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, N...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0442-2024%22) Feb 13, 2024 FDA drug enforcement ### [Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6](https://isitonrecall.com/recall/fda-drug-d-0327-2024-oseltamivir-phosphate-for-oral-suspension-6mg-ml-60-ml-reconstituted-bottle-rx-only-distributed-by-a/) Failed Impurities/Degradation Specifications: Out-of-specification test results. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distribu...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0327-2024%22) Jan 15, 2024 FDA drug enforcement ### [Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, ...](https://isitonrecall.com/recall/fda-drug-d-0319-2024-phenoxybenzamine-hydrochloride-capsules-usp-10mg-100-count-bottle-rx-only-manufactured-by-amneal-pha/) Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II Reported terminated Distribution: USA nationwide. [Official source for Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0319-2024%22) Dec 26, 2023 FDA drug enforcement ### [Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmace...](https://isitonrecall.com/recall/fda-drug-d-0426-2024-divalproex-sodium-extended-release-tablets-usp-250-mg-rx-only-100-tablets-manufactured-by-amneal-pha/) Failed dissolution specifications Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0426-2024%22) Oct 27, 2023 FDA drug enforcement ### [Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10](https://isitonrecall.com/recall/fda-drug-d-0090-2024-extended-phenytoin-sodium-capsules-usp-100-mg-100-count-bottle-distributed-by-amneal-pharmaceuticals/) Failed Dissolution Specifications Class II Reported terminated Distribution: Nationwide in the USA and Puerto Rico [Official source for Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmace...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0090-2024%22) May 30, 2023 FDA drug enforcement ### [Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.](https://isitonrecall.com/recall/fda-drug-d-0876-2023-extended-phenytoin-sodium-capsules-usp-100-mg-rx-only-100-capsules-per-bottle-distributed-by-amneal/) Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) Class II Reported terminated Distribution: LA, PA and OH. [Official source for Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0876-2023%22) May 8, 2023 FDA drug enforcement ### [Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, ...](https://isitonrecall.com/recall/fda-drug-d-0756-2023-methylprednisolone-acetate-injectable-suspension-usp-80-mg-ml-for-intramuscular-intrasynovial-and-so/) 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 III Reported terminated Distribution: Nationwide in the USA and PR [Official source for Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0756-2023%22) Jul 27, 2022 FDA drug enforcement ### [Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceut...](https://isitonrecall.com/recall/fda-drug-d-1362-2022-divalproex-sodium-extended-release-tablets-usp-250-mg-packaged-in-100-count-bottle-rx-only-manufactu/) Failed dissolution specifications. Class II Reported terminated Distribution: USA nationwide [Official source for Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1362-2022%22) Nov 4, 2021 FDA drug enforcement ### [Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86](https://isitonrecall.com/recall/fda-drug-d-0233-2022-flocinolone-acetonide-0-01-topical-oil-body-oil-rx-packaged-in-4-oz-bottle-distributed-by-amneal-pha/) Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Class II Reported terminated Distribution: Product was distributed nationwide within the United States [Official source for Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0233-2022%22) Nov 4, 2021 FDA drug enforcement ### [Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86](https://isitonrecall.com/recall/fda-drug-d-0234-2022-flocinolone-acetonide-0-01-topical-oil-scalp-oil-rx-packaged-in-4-oz-bottle-distributed-by-amneal-ph/) Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Class II Reported terminated Distribution: Product was distributed nationwide within the United States [Official source for Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by:...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0234-2022%22) ## Reasons in these listed records - Failed Dissolution Specifications - Superpotent Drug: Due to overfilling of drug powder - Failed Impurities/Degradation Specifications: Out-of-specification test results. - Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. These examples come from this result page and are not a ranking of every recall reason. ## Checking Amneal Pharmaceuticals of New York, LLC ### Is there a recall on amneal pharmaceuticals of new york, llc right now? 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. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? 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. ### What if the search finds no matching record? 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](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search Amneal Pharmaceuticals of New York, LLC](https://isitonrecall.com/check/?q=Amneal%20Pharmaceuticals%20of%20New%20York%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)