Direct Rx recalls 10mg Montelukast Sodium Tablets (Rx only) due to cGMP deviations. Affected products include 30-count and 90-count bottles with specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.
cGMP deviations
Direct Rx is recalling 10mg Montelukast Sodium Tablets (Rx only) because of cGMP deviations. This means the products may not meet quality standards, though the recall does not specify immediate health risks or a remedy.
cGMP deviations refer to failures in manufacturing quality control processes. This could mean the tablets may not be safe or effective, but the recall does not specify how this affects users or what health risks might arise.
Prescription medication users who purchased Direct Rx Montelukast Sodium Tablets (10mg) between 2021 and 2025. People with asthma or allergies who take this medication are most at risk.
Check for Direct Rx 10mg Montelukast Sodium Tablets (Rx only) in 30-count or 90-count bottles with specific lot numbers and expiration dates listed in the recall notice.
Look for the product name, lot number, and expiration date on the bottle to confirm if it is affected.
The recall mentions cGMP deviations but does not specify health risks or immediate dangers.
The recall does not provide a remedy, so contact Direct Rx for further instructions.
Check the lot number and expiration date on the bottle against the list provided in the recall notice.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0476-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0476-2023 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.
