Recalls / Active ingredient / Montelukast Sodium
Montelukast Sodium
5 FDA drug recalls involving the active ingredient “Montelukast Sodium” — 1 Class I.
| Date | Class | Product | Firm |
|---|---|---|---|
| 2023-10-13 | Class II | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., | Dr. Reddy's Laboratories, Inc. |
| 2023-02-07 | Class II | Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 | Accord Healthcare, Inc. |
| 2018-08-20 | Class II | Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polep | Hetero Labs Limited Unit V |
| 2018-08-15 | Class I | Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, | Hetero Labs Limited Unit V |
| 2017-01-07 | Class III | Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., P | Hetero USA Inc |