Amneal Pharmaceuticals of New York, LLC

Complete recall history across all FDA and CPSC categories — 25 total recalls

Amneal Pharmaceuticals of New York, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (25)

FDA drug safety enforcement actions by Amneal Pharmaceuticals of New York, LLC

Date Product Reason Class
Mar 25, 2024 Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... Failed Dissolution Specifications Class II
Mar 21, 2024 Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... Superpotent Drug: Due to overfilling of drug powder Class I
Feb 13, 2024 Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottl... Failed Impurities/Degradation Specifications: Out-of-specification test results. Class II
Jan 15, 2024 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... Failed Impurities/Degradation Specifications: Out of specification for unknow... Class II
Dec 26, 2023 Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets,... Failed dissolution specifications Class II
Oct 27, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... Failed Dissolution Specifications Class II
May 30, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... Failed Dissolution Specifications: Out-of-specification results for dissoluti... Class II
May 8, 2023 Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... Labeling: Not Elsewhere Classified; A typographical error was observed in the... Class III
Jul 27, 2022 Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... Failed dissolution specifications. Class II
Nov 4, 2021 Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bot... Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolo... Class II
Nov 4, 2021 Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bott... Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolo... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
May 29, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... Class II
Apr 15, 2020 Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di... CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels... Class II
Aug 3, 2017 Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... Defective Delivery System: the dropper measurement markings may be reversed, ... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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