Montelukast Sodium Tablets — Class II drug recall D-0086-2024
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2023-11-15, distributed nationwide. Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets
| Recall number | D-0086-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2023-10-13 |
| Classified | 2023-11-03 |
| Reported by FDA | 2023-11-15 |
| Terminated | 2024-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,656 bottles |
| NDC | 55111-0593, 55111-0593-05, 55111-0593-30, 55111-0593-78, 55111-0593-79, 55111-0593-90, 55111-0594, 55111-0594-05, 55111-0594-30, 55111-0594-78, 55111-0594-79, 55111-0594-90, 55111-0725, 55111-0725-01, 55111-0725-10, 55111-0725-30, 55111-0725-78, 55111-0725-79, 55111-0725-90 |
| Lot numbers | C2305569 |
| Expiration dates | 2026-03-31 |
Product
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Reason for recall
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
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-0086-2024. 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.