The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0829-2021·Announced 2021-09-29

Zonisamide 100 mg Capsules Recalled Due to Quality Control Gaps

Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.

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 an FDA Class II recall involving a CGMP deviation in quality control processes. The source text does not report any illnesses, injuries, or confirmed product defects—only procedural gaps in the laboratory system. Per the rubric, Class II recalls without reported hospitalization or injury typically score as Moderate (2).

Plain-English summary

Direct Rx is recalling Zonisamide 100 mg Capsules in 30-count bottles packaged and distributed by Direct Rx in Dawsonville, GA and manufactured for Glenmark Pharmaceuticals Inc., USA in Mahwah, NJ (NDC 61919-0775-30). The recall affects 2 bottles with Lot #17JU2118 and expiration date 5/31/23 distributed in Florida only.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations, specifically gaps in the quality system in the Quality Control microbiology laboratory.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on their treatment options. Do not discontinue use of this medication without consulting a healthcare professional, as doing so could pose health risks.

The recalled product

Product
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
Manufacturer
Direct Rx
Category
Drug — Antiepileptic / Seizure Medication
Hazard
Affected units
2

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 #: 17JU2118 Exp. 5/31/23

Distribution

Distributed in 1 state:

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