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. 14 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is nitrosamine impurity.
Total recalls 24 since 2017
Last 12 months 3 reported
Class I 3 13% of total
Ongoing 14 latest 17 Jun 2026
Recalls per month, last 24 months click a bar for that month Severity split
3 13%14 58%7 29%
Why amneal pharmaceuticals is recalled
Ongoing amneal pharmaceuticals recalls 14 active
All amneal pharmaceuticals recalls, newest first 24 total Reported Class Recall Company Reason Where 17 Jun 2026 Drug CLASS III Primidone Tablets, USP, 50 mg recalled by Amneal Pharmaceuticals Primidone Amneal Pharmaceuticals Other Nationwide 8 Apr 2026 Drug CLASS I Magnesium Sulfate in Water for Injection (40mg/mL) IV recalled Magnesium Sulfate Amneal Pharmaceuticals Packaging Defects Nationwide 8 Apr 2026 Drug CLASS II traMADol Hydrochloride Tablets, USP, 50 mg recalled Amneal Pharmaceuticals Nitrosamine Impurity Nationwide 10 Sep 2025 Drug CLASS II chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalled Chlorpromazine Hydrochloride Amneal Pharmaceuticals Packaging Defects Nationwide 10 Sep 2025 Drug CLASS II Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalled Sulfamethoxazole And Trimethoprim Amneal Pharmaceuticals Packaging Defects Nationwide 10 Sep 2025 Drug CLASS II chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled Chlorpromazine Hydrochloride Amneal Pharmaceuticals Packaging Defects Nationwide 10 Sep 2025 Drug CLASS II chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalled Chlorpromazine Hydrochloride Amneal Pharmaceuticals Packaging Defects Nationwide 10 Sep 2025 Drug CLASS II chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalled Chlorpromazine Hydrochloride Amneal Pharmaceuticals Packaging Defects Nationwide 18 Jun 2025 Drug CLASS I Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalled Sulfamethoxazole And Trimethoprim Amneal Pharmaceuticals Sterility Nationwide 14 May 2025 Drug CLASS I Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per (5mg/mL) recalled Ropivacaine Hydrochloride Amneal Pharmaceuticals Particulate Matter Nationwide 14 Aug 2024 Drug CLASS III Methotrexate Tablets, USP, 2.5mg recalled by Amneal Pharmaceuticals Amneal Pharmaceuticals Other Nationwide 18 Dec 2019 Drug CLASS II Ranitidine Syrup Oral Solution 15 mg/mL fl. oz recalled Amneal Pharmaceuticals Nitrosamine Impurity Nationwide 18 Dec 2019 Drug CLASS II Ranitidine Tablets, USP 150 mg recalled by Amneal Pharmaceuticals Ranitidine Amneal Pharmaceuticals Nitrosamine Impurity Nationwide 18 Dec 2019 Drug CLASS II Ranitidine Tablets, USP 150 mg a) recalled by Amneal Pharmaceuticals Amneal Pharmaceuticals Nitrosamine Impurity Nationwide 18 Dec 2019 Drug CLASS II Ranitidine Tablets, USP 300 mg recalled by Amneal Pharmaceuticals Ranitidine Amneal Pharmaceuticals Nitrosamine Impurity Nationwide 18 Dec 2019 Drug CLASS II Ranitidine Tablets, USP 300 mg - a) recalled by Amneal Pharmaceuticals Amneal Pharmaceuticals Nitrosamine Impurity Nationwide 20 Nov 2019 Drug CLASS III Isotretinoin Capsules, USP 10 mg recalled by Amneal Pharmaceuticals Isotretinoin Amneal Pharmaceuticals Potency & Assay NY 16 Oct 2019 Drug CLASS III Benazepril HCl Tablets, USP 40 mg recalled by Amneal Pharmaceuticals Benazepril Hydrochloride Amneal Pharmaceuticals Other Nationwide 31 Jul 2019 Drug CLASS III Methylergonovine Maleate recalled by Amneal Pharmaceuticals Amneal Pharmaceuticals Other Nationwide 10 Jul 2019 Drug CLASS III Esterified Estrogens & Methyltestosterone Tablets recalled Amneal Pharmaceuticals Potency & Assay Nationwide 10 Jul 2019 Drug CLASS III Esterified Estrogens & Methyltestosterone Tablets recalled Amneal Pharmaceuticals Potency & Assay Nationwide 4 Apr 2018 Drug CLASS II Fosphenytoin Sodium Injection, USP 500 mg PE* recalled Amneal Pharmaceuticals Particulate Matter Nationwide 22 Nov 2017 Drug CLASS II Fosphenytoin Sodium Injection, USP, 500 mg PE recalled Amneal Pharmaceuticals Particulate Matter 5 states 10 May 2017 Drug 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.