Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zonisamide Capsules USP Recalled by Direct Rx Due to CGMP Deviations: Gaps in the quality system in...
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 Direct Rx directly.
Affected Products
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Quantity: 16 bottles
Why Was This Recalled?
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Direct Rx
Direct Rx has 36 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