Montelukast Sodium Tablets — Class II drug recall D-0476-2023
Terminated recall by Direct Rx, reported 2023-04-05, distributed nationwide. cGMP deviations
| Recall number | D-0476-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2023-03-13 |
| Classified | 2023-03-24 |
| Reported by FDA | 2023-04-05 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 61919-0009-30, 61919-0009-90 |
| Lot numbers | 06JU2208, 10DE2123, 10JU2111, 12JA2305, 13SE2132, 14DE2216, 14JY2115, 14SE2111, 16JU2127, 18MY2126, 20JU2211, 21JA2202, 21SE2227, 22NO2115, 23NO2203, 25JU2128, 25JU2133, 25OC2113, 28FE2227, 29DE2110, 30AU2216, 30MA2229 |
| Expiration dates | 2023-12-31, 2024-01-31, 2024-02-29, 2024-03-31, 2024-04-30, 2024-05-31, 2024-06-30, 2025-07-31 |
Product
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason for recall
cGMP deviations
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-0476-2023. 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.