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.

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 month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 17%Class II 3 50%Class III 2 33%

Why montelukast sodium is recalled

Companies

Product types

Inhalers & Asthma Medication6100%

By year

2023233%
2020117%
2018233%
2017117%

Ongoing montelukast sodium recalls

1 active

Reported	Class	Recall	Company	Reason	Where
3 Oct 2018Drug	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
15 Nov 2023Drug	CLASS II	Montelukast Sodium Tablets, USP 10 mg recalledMontelukast Sodium	Dr. Reddy's Laboratories	Other	Nationwide
8 Mar 2023Drug	CLASS II	Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
5 Feb 2020Drug	CLASS III	Montelukast Sodium Chewable Tablets, 5 mg recalledMontelukast Sodium	Macleods Pharma Usa	Potency & Assay	Nationwide
3 Oct 2018Drug	CLASS I	Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium	Hetero Labs Limited Unit V	Packaging Defects	Nationwide
3 Oct 2018Drug	CLASS II	Montelukast Sodium Tablets, 10 mg* recalledMontelukast Sodium	Hetero Labs Limited Unit V	Other	Nationwide
5 Apr 2017Drug	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.