Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AVKARE Ranitidine Tablets Recalled by AVKARE 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 AVKARE Inc. directly.
Affected Products
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Quantity: 104,797 bottles
Why Was This Recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AVKARE Inc.
AVKARE Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report