Montelukast Sodium Chewable Tablets — Class III drug recall D-0823-2020
Terminated recall by Macleods Pharma Usa Inc, reported 2020-02-05, distributed nationwide. Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
| Recall number | D-0823-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2020-01-20 |
| Classified | 2020-01-31 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2021-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 10,680 units |
| Reason classes | specification failure |
| NDC | 33342-0110, 33342-0110-07, 33342-0110-10, 33342-0110-12, 33342-0110-15, 33342-0110-39, 33342-0110-44, 33342-0111, 33342-0111-07, 33342-0111-10, 33342-0111-12, 33342-0111-15, 33342-0111-39, 33342-0111-44 |
| Lot numbers | BMD8901B |
| Expiration dates | 2021-02 |
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 for recall
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0823-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.