FDA Drug recall D-0823-2020
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc
- FDA Drug
- Class III
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class III recall of Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc by Macleods Pharma Usa, citing failed Dissolution Specifications: testing revealed low out of specification result in one lot of product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0823-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-01-20 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Reason
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Identifiers
| ndc | 33342-110-07 |
|---|---|
| ndc | 33342-110-10 |
| ndc | 33342-110-15 |
| ndc | 33342-110-12 |
| ndc | 33342-110-39 |
| ndc | 33342-110-44 |
| ndc | 33342-111-07 |
| ndc | 33342-111-10 |
| ndc | 33342-111-15 |
| ndc | 33342-111-12 |
| ndc | 33342-111-39 |
| ndc | 33342-111-44 |
| code_info | Lot #: BMD8901B, Exp. Date 02/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0823-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.