Endo USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
10 (5 Class I)
510(k) Clearances
0
Inspections
46
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0141-2026Class IIIEverolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), RxOctober 10, 2025
D-0139-2026Class IIIEverolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx oOctober 10, 2025
D-0140-2026Class IIIEverolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), RxOctober 10, 2025
D-0142-2026Class IIIEverolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), ROctober 10, 2025
D-0026-2026Class IIIEverolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx oSeptember 5, 2025
D-0223-2025Class IAdrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mLDecember 20, 2024
D-0179-2025Class IClonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blNovember 18, 2024
D-0178-2025Class IClonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blisterNovember 18, 2024
D-0181-2025Class IClonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blisteNovember 18, 2024
D-0180-2025Class IClonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 bliNovember 18, 2024