ENDO USA, Inc.
ENDO USA, Inc. appears in FDA public data with 11 recalls — including 5 Class I (most serious) —, 0 510(k) clearances, 30 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0527-2026, Class II) was initiated on March 13, 2026.
Summary
- Total Recalls
- 11 (5 Class I)
- 510(k) Clearances
- 0
- Inspections
- 30
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0527-2026 | Class II | Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured fo | March 13, 2026 |
| D-0140-2026 | Class III | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx | October 10, 2025 |
| D-0142-2026 | Class III | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), R | October 10, 2025 |
| D-0139-2026 | Class III | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx o | October 10, 2025 |
| D-0141-2026 | Class III | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx | October 10, 2025 |
| D-0026-2026 | Class III | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx o | September 5, 2025 |
| D-0223-2025 | Class I | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL | December 20, 2024 |
| D-0181-2025 | Class I | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 bliste | November 18, 2024 |
| D-0180-2025 | Class I | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 bli | November 18, 2024 |
| D-0178-2025 | Class I | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister | November 18, 2024 |
| D-0179-2025 | Class I | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 bl | November 18, 2024 |