Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ranitidine Tablets Recalled by Amneal Pharmaceuticals, Inc. Due to CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amneal Pharmaceuticals, Inc. directly.
Affected Products
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Quantity: N/A
Why Was This Recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Where Was This Sold?
Product was distributed throughout the United States.
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report