Endo USA, Inc. 2025-01-15 Health critical FDA
Health · FDA · Recall #FDA-D-0179-2025
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per… Recall
Issued January 15, 2025 · Endo USA, Inc.
In January 2025, Endo USA, Inc. recalled the Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
What you should do
- 1 Stop using Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Endo USA, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Endo USA, Inc.
- Category
- Health
- Recall date
- January 15, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0179-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Endo USA, Inc. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.