Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mesalamine Delayed-Release Tablets Recalled by AVKARE Inc. Due to Failed Dissolution Specifications
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 AVKARE Inc. directly.
Affected Products
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
Quantity: 15,678 bottles
Why Was This Recalled?
Failed Dissolution Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AVKARE Inc.
AVKARE Inc. has 33 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