FlaggedRx · Recall check

Montelukast recalls — live FDA check

14 FDA recall record(s) mention “Montelukast”, 1 Class I (most serious) · checked Jul 05, 2026

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.

Is Montelukast still recalled? (current status)

The records above are FDA enforcement entries. An FDA status of “Terminated” or “Completed” is an administrative state — it means FDA closed the recall action, not that any particular bottle is unaffected. Always match the lot number on your medicine to the record and ask your pharmacist.

Common questions

Should I stop taking a recalled medication?
Don't stop a prescribed medicine on your own. A recall often affects only specific lots. Check your lot number against the record, then call your pharmacist or doctor about a replacement. Stopping some medicines abruptly is itself dangerous.
How do I find my lot number?
It's printed on the box or bottle label, usually near the expiry date and marked “Lot”, “LOT”, or “L”. Match it to the affected lots listed on each recall record.
What do Class I, II, and III mean?
FDA's classes: Class I — reasonable chance of serious harm or death; Class II — temporary or reversible harm, serious harm unlikely; Class III — unlikely to cause harm (often a labeling or packaging issue). These are FDA's definitions.

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Source: U.S. FDA enforcement database (openFDA), checked live. Each record links to its FDA source.