Zonisamide Capsules USP recalled for quality control system deviation
Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall triggered by manufacturing quality control system gaps with no reported illnesses, hospitalizations, or confirmed product contamination. FDA Class II classification without evidence of actual harm meets the criteria for Moderate severity.
Plain-English summary
Direct Rx is recalling Zonisamide Capsules USP, 100 mg, 90-count bottles (NDC 61919-775-90) distributed nationwide. The affected lot is 23JY2124, which expires 6/30/23. The product was manufactured for Glenmark Pharmaceuticals Inc., USA.
The recall was initiated due to gaps identified in the quality system within the Quality Control microbiology laboratory. These deficiencies could affect the ability to verify that the product meets required specifications.
Patients currently taking this medication should contact their pharmacist or healthcare provider. No illnesses or adverse events have been reported in connection with this recall.
The recalled product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 23JY2124 Exp. 6/30/23
Distribution
Distributed nationwide across the United States.
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