Amneal Pharmaceuticals recalls

Amneal Pharmaceuticals has 25 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 7 Oct 2026. 15 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is nitrosamine impurity.

Total recalls25since 2017

Last 12 months4reported

Class I312% of total

Ongoing15latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 1 1Jun 0 0 5Sep 0 0 0Dec 0 0 0Mar 2 0 1Jun 0 0 0Sep 1 0

Severity split

Class I 3 12%Class II 15 60%Class III 7 28%

Why amneal pharmaceuticals is recalled

Product types

Brands

By year

2026416%
2025728%
202414%
20191040%
201814%
201728%

Ongoing amneal pharmaceuticals recalls

15 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol	Amneal Pharmaceuticals	Other	Nationwide
17 Jun 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone	Amneal Pharmaceuticals	Other	Nationwide
8 Apr 2026Drug	CLASS I	Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate	Amneal Pharmaceuticals	Packaging Defects	Nationwide
8 Apr 2026Drug	CLASS II	traMADol Hydrochloride Tablets, USP, 50 mg recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Packaging Defects	Nationwide

All amneal pharmaceuticals recalls, newest first

25 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol	Amneal Pharmaceuticals	Other	Nationwide
17 Jun 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone	Amneal Pharmaceuticals	Other	Nationwide
8 Apr 2026Drug	CLASS I	Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate	Amneal Pharmaceuticals	Packaging Defects	Nationwide
8 Apr 2026Drug	CLASS II	traMADol Hydrochloride Tablets, USP, 50 mg recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
18 Jun 2025Drug	CLASS I	Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Sterility	Nationwide
14 May 2025Drug	CLASS I	Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per (5mg/mL) recalledRopivacaine Hydrochloride	Amneal Pharmaceuticals	Particulate Matter	Nationwide
14 Aug 2024Drug	CLASS III	Methotrexate Tablets, USP, 2.5mg recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Other	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Syrup Oral Solution 15 mg/mL fl. oz recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg a) recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by Amneal PharmaceuticalsRanitidine	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg - a) recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS III	Isotretinoin Capsules, USP 10 mg recalled by Amneal PharmaceuticalsIsotretinoin	Amneal Pharmaceuticals	Potency & Assay	NY
16 Oct 2019Drug	CLASS III	Benazepril HCl Tablets, USP 40 mg recalled by Amneal PharmaceuticalsBenazepril Hydrochloride	Amneal Pharmaceuticals	Other	Nationwide
31 Jul 2019Drug	CLASS III	Methylergonovine Maleate recalled by Amneal Pharmaceuticals	Amneal Pharmaceuticals	Other	Nationwide
10 Jul 2019Drug	CLASS III	Esterified Estrogens & Methyltestosterone Tablets recalled	Amneal Pharmaceuticals	Potency & Assay	Nationwide
10 Jul 2019Drug	CLASS III	Esterified Estrogens & Methyltestosterone Tablets recalled	Amneal Pharmaceuticals	Potency & Assay	Nationwide
4 Apr 2018Drug	CLASS II	Fosphenytoin Sodium Injection, USP 500 mg PE* recalled	Amneal Pharmaceuticals	Particulate Matter	Nationwide
22 Nov 2017Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalled	Amneal Pharmaceuticals	Particulate Matter	5 states
10 May 2017Drug	CLASS II	Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) bottle recalled	Amneal Pharmaceuticals	Potency & Assay	Nationwide

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.