Direct Rx Zonisamide Capsules Recall: Quality Control Gaps
Direct Rx recalls 100mg Zonisamide capsules due to quality control gaps in microbiology testing. Affected lots from June 2023 expire June 30, 2023. No remedy specified in official notice.
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 100mg Zonisamide capsules that were manufactured with quality control gaps in their microbiology testing. This recall affects specific lots that expire June 30, 2023, but no action is required as the official notice does not specify a remedy. Read more at govinfonow.com/recall/34716-direct-rx-zonisamide-capsules-recall-quality-control-gaps.
Source Summary by GovInfoNow · govinfonow.com/recall/34716-direct-rx-zonisamide-capsules-recall-quality-control-gaps · Updated August 18, 2026 · FDA enforcement record: FDA #D-0888-2022
Cite this page
“Direct Rx Zonisamide Capsules Recall: Quality Control Gaps.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34716-direct-rx-zonisamide-capsules-recall-quality-control-gaps. Based on FDA recall #D-0888-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0888-2022%22&limit=1).
Why it’s dangerous
The recall is due to gaps in the quality control microbiology laboratory, which could potentially affect the safety and purity of the medication. However, the official notice does not specify the exact risk level or how this might impact patient safety.
Who’s affected
Prescription patients who received Zonisamide capsules from Direct Rx in the US. Those with specific lot numbers (23JY2124) and expiration dates (June 30, 2023) are most at risk.
How to tell if you have this one
Check for the product name 'Zonisamide Capsules USP, 100 mg, 90-count bottle' with lot number 23JY2124 and expiration date June 30, 2023. The product was distributed by Direct Rx in Dawsonville, GA.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number (23JY2124) and expiration date (June 30, 2023) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide to the U.S. market” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years 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.
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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-0888-2022 (May 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0888-2022 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.