Montelukast Granules recalls
The FDA has published 2 recalls involving Montelukast Granules since 2017. The latest was reported on 12 Apr 2023. Most were for potency & assay. Teva Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls2since 2017
Last 12 months0reported
Class I00% of total
Ongoing0latest 12 Apr 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 0 0%Class III 2 100%
Why montelukast granules is recalled
Companies
By year
All montelukast granules recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Montelukast Sodium Oral Granules USP, 4 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Montelukast Sodium Oral Granules, 4 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Should you stop taking Montelukast Granules?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.