Amneal Pharmaceuticals of New York recalls

Amneal Pharmaceuticals of New York has 27 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 30 Sep 2026. 13 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is nitrosamine impurity.

Total recalls27since 2013

Last 12 months1reported

Class I27% of total

Ongoing13latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 2 7%Class II 24 89%Class III 1 4%

Why amneal pharmaceuticals of new york is recalled

Product types

Brands

By year

202614%
2024519%
2023311%
202214%
202127%
20201348%
201714%
201314%

Ongoing amneal pharmaceuticals of new york recalls

13 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Exenatide Injection, USP, 250 mcg/mL per prefilled pen recalledExenatide	Amneal Pharmaceuticals of New York	Other	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide

All amneal pharmaceuticals of new york recalls, newest first

27 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Exenatide Injection, USP, 250 mcg/mL per prefilled pen recalledExenatide	Amneal Pharmaceuticals of New York	Other	Nationwide
8 May 2024Drug	CLASS II	Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
24 Apr 2024Drug	CLASS I	Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
3 Apr 2024Drug	CLASS II	Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
28 Feb 2024Drug	CLASS II	Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
14 Feb 2024Drug	CLASS II	Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
15 Nov 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
21 Jun 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	LA, OH, PA
31 May 2023Drug	CLASS III	Methylprednisolone Acetate Injectable Suspension recalled	Amneal Pharmaceuticals of New York	Packaging Defects	Nationwide
31 Aug 2022Drug	CLASS II	Divalproex Sodium Extended Release Tablets, USP, 250 mg recalledDivalproex Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
24 Nov 2021Drug	CLASS II	Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx recalled	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
24 Nov 2021Drug	CLASS II	Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx recalled	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
6 May 2020Drug	CLASS II	Nizatidine Oral Solution, 15 mg/mL (75 mg recalledNizatidine	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
27 Dec 2017Drug	CLASS I	Lorazepam Oral Concentrate, USP, 2 mg/mL recalledLorazepam	Amneal Pharmaceuticals of New York	Other	Nationwide
13 Nov 2013Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	7 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.