U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  1. Safety

Recalls, Market Withdrawals, & Safety Alerts

The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.

The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
Email Icon for GovDeliverySign up to receive Recalls, Market Withdrawals and Safety Alerts.
* FDA Employees: Use Chrome to Subscribe until further notice.


A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Date Brand Name(s) Product Description Product Type Recall Reason Description Company Name Terminated Recall
American Health Packaging Ranitidine Tablets, USP 150mg Drugs NDMA (Nitrosodimethylamine) impurity American Health Packaging
Northwind Ranitidine Tablets 150mg and 300mg Drugs NDMA (Nitrosodimethylamine) impurity Denton Pharma, Inc. dba Northwind Pharmaceuticals
ani Ranitidine Tablets 150mg and 300mg Drugs NDMA (Nitrosodimethylamine) impurity Appco Pharma LLC Terminated
Glenmark Ranitidine Tablets 150mg and 300mg Drugs NDMA (Nitrosodimethylamine) impurity Glenmark Pharmaceuticals, Inc.
Amneal Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL Drugs Due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA Amneal Pharmaceuticals, LLC
PrecisionDose Ranitidine Oral Solution, USP 150 mg/10 mL Drugs Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Precision Dose Inc.
GSMS Incorporated Ranitidine HCl 150mg and 300mg Capsules Drugs Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA GSMS, Inc.
AHP Ranitidine Liquid Unit Dose Cups Drugs NDMA (Nitrosodimethylamine) impurity American Health Packaging
Aurobindo & DG Health Ranitidine Drugs NDMA (Nitrosodimethylamine) Aurobindo Pharma USA, Inc.
Novitium Pharma Ranitidine Hydrochloride Capsules 150 mg and 300 mg Drugs May contain N-Nitrosodimethylamine (NDMA) Novitium Pharma
Back to Top