Amneal Pharmaceuticals recalls

Amneal Pharmaceuticals has 24 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 17 Jun 2026. 15 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is nitrosamine impurity.

Total recalls24since 2017

Last 12 months3reported

Class I313% of total

Ongoing15latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 1 1 0Jul 0 5 0Oct 0 0 0Jan '26 0 0 2Apr 0 1 0Jul 0 0

Severity split

Class I 3 13%Class II 14 58%Class III 7 29%

Why amneal pharmaceuticals is recalled

Product types

Brands

By year

2026313%
2025729%
202414%
20191042%
201814%
201728%

Ongoing amneal pharmaceuticals recalls

15 active

Reported	Class	Recall	Company	Reason	Where
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 recalledTramadol Hydrochloride	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

All amneal pharmaceuticals recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
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 recalledTramadol Hydrochloride	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, 5%, 500 mg per (5mg/mL) recalledRopivacaine Hydrochloride	Amneal Pharmaceuticals	Particulate Matter	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.