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.
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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.
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.
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.
Check for 30-count bottles labeled 'Zonisamide 100 mg' with Direct Rx packaging. The expiration date is May 31, 2023 (Lot #17JU2118).
Discard all affected capsules as they may contain unsafe levels of bacteria.
The recall states there were quality control gaps in microbiology testing, so the medication may not be safe. Do not use these capsules.
Check for 30-count bottles labeled 'Zonisamide 100 mg' with Direct Rx packaging and expiration date May 31, 2023 (Lot #17JU2118).
Discard all affected capsules immediately and contact your doctor for alternative medication options.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0829-2021 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0829-2021 from Direct Rx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
