Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nizatidine Capsules Recalled by Mylan Pharmaceuticals Inc. Due to CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine...
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 Mylan Pharmaceuticals Inc. directly.
Affected Products
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Quantity: 16,944 bottles of 30 capsules
Why Was This Recalled?
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Where Was This Sold?
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
About Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report