FDA Drug recall D-0086-2024
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in…
- FDA Drug
- Class II
- terminated
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in… by Dr Reddy S Laboratories, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0086-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-10-13 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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.
Identifiers
| ndc | 55111-725-30 |
|---|---|
| ndc | 55111-725-90 |
| ndc | 55111-725-01 |
| ndc | 55111-725-10 |
| ndc | 55111-725-79 |
| ndc | 55111-725-78 |
| ndc | 55111-593-30 |
| ndc | 55111-593-90 |
| ndc | 55111-593-05 |
| ndc | 55111-593-79 |
| ndc | 55111-593-78 |
| ndc | 55111-594-30 |
| ndc | 55111-594-90 |
| ndc | 55111-594-05 |
| ndc | 55111-594-79 |
| ndc | 55111-594-78 |
| code_info | Lot # C2305569, Exp. date 03/31/2026 |
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-0086-2024%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.