FDA Drug recall D-0622-2024
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only,…
- FDA Drug
- Class I
- terminated
- Published 2024-08-07
On 2024-08-07 the FDA classified a Class I recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only,… by Endo Pharmaceuticals, citing labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0622-2024 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2024-07-10 |
| Published | 2024-08-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Endo Pharmaceuticals |
| Distribution | US |
Product
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Identifiers
| ndc | 49884-306-02 |
|---|---|
| ndc | 49884-307-02 |
| ndc | 49884-308-02 |
| ndc | 49884-309-02 |
| ndc | 49884-310-02 |
| code_info | Lot 550147301, Exp. 08/31/2026 |
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-0622-2024%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.