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Amneal Pharmaceuticals of New York Recalls
26 recalls on record · November 13, 2013 to May 8, 2024 · Drugs
Recalls by year
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24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 8, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bri
Hazard: Failed Dissolution Specifications
April 24, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15
Hazard: Superpotent Drug: Due to overfilling of drug powder
April 3, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: Failed dissolution specifications
February 28, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceu
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification test results.
February 14, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
November 15, 2023DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater
Hazard: Failed Dissolution Specifications
June 21, 2023DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutical
Hazard: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
May 31, 2023DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injecti
Hazard: 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.
August 31, 2022DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal
Hazard: Failed dissolution specifications.
November 24, 2021DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals
Hazard: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
November 24, 2021DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals
Hazard: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal P
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Phar
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharm
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amnea
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewat
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amn
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amne
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amne
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
May 6, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Brid
Hazard: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
December 27, 2017DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ
Hazard: Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
November 13, 2013DrugsFDA
Amneal Pharmaceuticals of New York, LLC. recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11
Hazard: Failed dissolution specifications; 18 month CRT