CLASS I ONGOING Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV recalled
Endo USA is recalling Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, distributed nationwide in the US. The recall was initiated on 18 Nov 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0179-2025
- FDA event ID
- 95778
- Recalling firm
- Endo USA, Malvern, PA
- Brand
- Clonazepam
- Manufacturer
- Par Health USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Nov 2024
- FDA classified
- 3 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Anxiety & Sleep Medication
Timeline
| 18 Nov 2024 | Recall initiated by company | |
| 3 Jan 2025 | Classified by FDA | +46 days |
| 15 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Which lots are affected?
Lot #: 550174101, Exp. 01/31/2027.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide | |
| CLASS I | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide | |
| CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
More recalls from Endo USA
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride | Endo USA | Other | Nationwide |
| Drug | CLASS III | Everolimus tablets 5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 10 mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 2.5 mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 7.5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
Other Clonazepam recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS III | Clonazepam Tablets, USP, 0.5 mg recalled by Mylan Institutional, Inc. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Potency & Assay | Nationwide |