CLASS I Drug recall · Reported 7 Aug 2024 · FDA Enforcement Report
Clonazepam Orally Disintegrating Tablets recalled
Endo Pharmaceuticals is recalling Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg per carton (10 blister cards, distributed nationwide in the US. The recall was initiated on 10 Jul 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-0622-2024
- FDA event ID
- 94945
- Recalling firm
- Endo Pharmaceuticals, Malvern, PA
- Brand
- Clonazepam
- Manufacturer
- Par Health USA, LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Jul 2024
- FDA classified
- 30 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Anxiety & Sleep Medication
Timeline
| 10 Jul 2024 | Recall initiated by company | |
| 30 Jul 2024 | Classified by FDA | +20 days |
| 7 Aug 2024 | Published in enforcement report | +8 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 as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 550147301, Exp. 08/31/2026
Where was it sold?
Nationwide in the USA and Puerto Rico
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.
More recalls from Endo Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcitonin Salmon Nasal Spray recalled by Endo PharmaceuticalsCalcitonin Salmon | Endo Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | robaxin-750 (methocarbamol tablets, USP), 750 mg recalled | Endo Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex | Endo Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg recalled | Endo Pharmaceuticals | Other | 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, USP, 0.125 mg, C-IV recalledClonazepam | Endo USA | 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 |