Montelukast recalls

The FDA has published 11 recalls involving Montelukast since 2013. The latest was reported on 15 Nov 2023. Most were for manufacturing (cgmp) deviations. Hetero Labs Limited Unit V 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 recalls11since 2013

Last 12 months0reported

Class I19% of total

Ongoing2latest 15 Nov 2023

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 9%Class II 7 64%Class III 3 27%

Why montelukast is recalled

Companies

By year

2023545%
202019%
2018218%
201719%
201419%
201319%

Ongoing montelukast recalls

2 active

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023Drug	CLASS II	Montelukast Sodium Tablets, USP, 10 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	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

All montelukast recalls, newest first

11 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
10 May 2023Drug	CLASS II	Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Montelukast Sodium Tablets, USP, 10 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Montelukast Sodium Tablets recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	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
29 Jan 2014Drug	CLASS II	Montelukast Sodium, Chew Tablet, 4 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
13 Mar 2013Drug	CLASS III	Montelukast Sodium Tablets, 10 mg (base) recalled	Glenmark Generics Inc. USA	Packaging Defects	Nationwide

Should you stop taking Montelukast?

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.