Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ranitidine Capsules 300 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 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Quantity: 1,632 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.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report