Endo USA, Inc. 2025-11-05 Health moderate FDA
Health · FDA · Recall #FDA-D-0140-2026
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7… Recall
Issued November 5, 2025 · Endo USA, Inc.
In November 2025, Endo USA, Inc. recalled the Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What you should do
- 1 Stop using Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7… 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
- November 5, 2025
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0140-2026
- 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.