FDA Drug Recalls

Recalls / Brands / Montelukast Sodium

Montelukast Sodium

6 FDA drug recalls involving brand “Montelukast Sodium1 Class I.

DateClassProductFirm
2023-10-13Class IIMontelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Dr. Reddy's Laboratories, Inc.
2023-02-07Class IIMontelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 Accord Healthcare, Inc.
2020-01-20Class IIIMontelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Macleods Pharma Usa Inc
2018-08-20Class IIMontelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, PolepHetero Labs Limited Unit V
2018-08-15Class IMontelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally,Hetero Labs Limited Unit V
2017-01-07Class IIIMontelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., PHetero USA Inc