Clonazepam Orally Disintegrating Tablets, USP, 0
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Agency
- FDA Drug
- Recall date
- Nov 18, 2024
- Status
- Ongoing
- Company
- Endo USA, Inc.
1. What product was recalled?
Clonazepam Orally Disintegrating Tablets, USP, 0
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).
Quantity: 8,029 cartons
Code or lot text: Lot #: 550174101, Exp. 01/31/2027.
- LOT
- Exp. 01/31/2027.
- LOT
- Lot #: 550174101
- NDC
- 49884-306
- NDC
- 49884-306-02
- NDC
- 49884-306-52
- NDC
- 49884-307
- NDC
- 49884-307-02
- NDC
- 49884-308
- NDC
- 49884-308-02
- NDC
- 49884-309
- NDC
- 49884-309-02
- NDC
- 49884-310
- NDC
- 49884-310-02
- RECALL-NUMBER
- D-0179-2025
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.