Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Famotidine for Oral Suspension Recalled by Novel Laboratories, Inc. Due to Failed Impurity/Degradation Specification; 12-month stability time point
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 Novel Laboratories, Inc. directly.
Affected Products
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Quantity: 25,776 containers
Why Was This Recalled?
Failed Impurity/Degradation Specification; 12-month stability time point
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Novel Laboratories, Inc.
Novel Laboratories, Inc. 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