Direct Rx Zonisamide 100mg Capsules Recall: Quality Control Issues
Direct Rx recalls 30-count Zonisamide 100mg capsules due to quality control gaps in microbiology testing. Affected lots from May 2023 expire May 31, 2023. Stop using immediately.
Recall notice
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Contact the company
What happened, in plain English
Direct Rx is recalling 30-count Zonisamide 100mg capsules because of quality control gaps in their microbiology lab. This could affect safety if the medication isn't properly tested. People who bought these capsules from Direct Rx in the US should stop using them immediately. Read more at govinfonow.com/recall/35855-direct-rx-zonisamide-100mg-capsules-recall-quality-control-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/35855-direct-rx-zonisamide-100mg-capsules-recall-quality-control-issues · Updated August 18, 2026 · FDA enforcement record: FDA #D-0829-2021
Cite this page
“Direct Rx Zonisamide 100mg Capsules Recall: Quality Control Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35855-direct-rx-zonisamide-100mg-capsules-recall-quality-control-issues. Based on FDA recall #D-0829-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0829-2021%22&limit=1).
Why it’s dangerous
The recall is due to gaps in the quality control system for microbiology testing. This means the medication might not be properly tested for safety, which could lead to health risks if the capsules contain harmful bacteria or other contaminants.
Who’s affected
People who bought Direct Rx's Zonisamide 100mg capsules in the US between May 2023 and May 31, 2023. Those with seizure disorders prescribed this medication are most at risk.
How to tell if you have this one
Check for 30-count bottles labeled 'Zonisamide 100 mg' with Direct Rx packaging. The expiration date is May 31, 2023 (Lot #17JU2118).
- Brand
Direct Rx- Category
Drug
What to do — step by step
Stop Using Immediately
Discard all affected capsules as they may contain unsafe levels of bacteria.
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “FL only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 38 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
Discard all affected capsules immediately and contact your doctor for alternative medication options.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0829-2021 (September 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0829-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.