Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zonisamide 100 mg Capsules 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 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
Quantity: 2 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 to 1 state: FL
About Direct Rx
Direct Rx has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report