FDA Drug recall D-0237-2024
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…
- FDA Drug
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed… by Ascend Laboratories, citing presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0237-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-29 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Reason
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Identifiers
| ndc | 67877-626-90 |
|---|---|
| ndc | 67877-626-01 |
| ndc | 67877-626-05 |
| ndc | 67877-626-06 |
| code_info | 23140190, Exp. Date 12/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0237-2024%22
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