Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nizatidine Oral Solution Recalled by Amneal Pharmaceuticals of New York, LLC Due to CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels...
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 of New York, LLC directly.
Affected Products
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Quantity: 11258 bottles
Why Was This Recalled?
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals of New York, LLC has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report