Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ranitidine Capsules 150 mg Recalled by Appco Pharma LLC 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 Appco Pharma LLC directly.
Affected Products
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
Quantity: 624 bottes
Why Was This Recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Where Was This Sold?
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
About Appco Pharma LLC
Appco Pharma LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report