Clonazepam Orally Disintegrating Tablets — Class I drug recall D-0179-2025
Ongoing recall by Endo USA, Inc., reported 2025-01-15, distributed nationwide. Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside t
| Recall number | D-0179-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endo USA, Inc., Malvern, PA, United States |
| Recall initiated | 2024-11-18 |
| Classified | 2025-01-03 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 8,029 cartons |
| Reason classes | labeling, potency |
| NDC | 49884-0306, 49884-0306-02, 49884-0306-52, 49884-0307, 49884-0307-02, 49884-0308, 49884-0308-02, 49884-0309, 49884-0309-02, 49884-0310, 49884-0310-02 |
| Lot numbers | 550174101 |
| Expiration dates | 2027-01-31 |
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.125 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#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
Reason for recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
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-0179-2025. 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.