CLASS III ONGOING Drug recall · Reported 22 Oct 2025 · FDA Enforcement Report
Everolimus tablets 5mg (each carton contains 4 blister recalled
Endo USA is recalling Everolimus tablets 5mg (each carton contains 4 blister strips with each), distributed nationwide in the US. The recall was initiated on 5 Sep 2025 and the FDA has classified it as Class III.
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-0026-2026
- FDA event ID
- 97557
- Recalling firm
- Endo USA, Malvern, PA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 5 Sep 2025
- FDA classified
- 16 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Sep 2025 | Recall initiated by company | |
| 16 Oct 2025 | Classified by FDA | +41 days |
| 22 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Which lots are affected?
Lot #: 550172301, Exp. Date January 2026
Where was it sold?
Nationwide within the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 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 |