Montelukast Sodium recalls
Montelukast Sodium products have been recalled 6 times, most recently on 15 Nov 2023. The recalling company is usually Hetero Labs Limited Unit V. The most common reason is packaging defects.
Total recalls6since 2017
Last 12 months0reported
Class I117% of total
Ongoing1latest 15 Nov 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 1 17%Class II 3 50%Class III 2 33%
Why montelukast sodium is recalled
Companies
Product types
By year
Ongoing montelukast sodium recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium | Hetero Labs Limited Unit V | Packaging Defects | Nationwide |
All montelukast sodium recalls, newest first
6 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Montelukast Sodium Tablets, USP 10 mg recalledMontelukast Sodium | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS III | Montelukast Sodium Chewable Tablets, 5 mg recalledMontelukast Sodium | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS I | Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium | Hetero Labs Limited Unit V | Packaging Defects | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, 10 mg* recalledMontelukast Sodium | Hetero Labs Limited Unit V | Other | Nationwide |
| Drug | CLASS III | Montelukast sodium tablets, 10 mg recalled by Hetero USAMontelukast Sodium | Hetero USA | Packaging Defects | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.