Montelukast Sodium Oral Granules USP — Class III drug recall D-0510-2023
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2023-04-12, distributed nationwide. Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
| Recall number | D-0510-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2023-03-27 |
| Classified | 2023-04-06 |
| Reported by FDA | 2023-04-12 |
| Terminated | 2023-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 3,772 cartons |
| Reason classes | specification failure |
| NDC | 00093-7487-19, 00093-7487-56 |
| Lot numbers | 3007556A |
| Expiration dates | 2023-05 |
Product
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Reason for recall
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
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-0510-2023. 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.