FDA Drug recall D-0181-2025
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Dis…
- FDA Drug
- Class I
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class I recall of Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Dis… by Endo Usa, citing labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0181-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-11-18 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Endo Usa |
| Distribution | US |
Product
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Identifiers
| ndc | 49884-306-02 |
|---|---|
| ndc | 49884-307-02 |
| ndc | 49884-308-02 |
| ndc | 49884-309-02 |
| ndc | 49884-310-02 |
| ndc | 49884-309-52 |
| code_info | Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027 |
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-0181-2025%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.