Endo USA, Inc. Provisional
FDA Flags (11)
Class II RecallMay 2026
ENDO USA, Inc.
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern
Classification: Class II
Class III RecallNov 2025
Endo USA, Inc.
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Classification: Class III
Class III RecallNov 2025
Endo USA, Inc.
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Classification: Class III
Class III RecallNov 2025
Endo USA, Inc.
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Classification: Class III
Class III RecallNov 2025
Endo USA, Inc.
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Classification: Class III
Class III RecallOct 2025
Endo USA, Inc.
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Classification: Class III
Class I RecallFeb 2025
ENDO USA, Inc.
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed
Classification: Class I
Class I RecallJan 2025
Endo USA, Inc.
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containi
Classification: Class I
Class I RecallJan 2025
Endo USA, Inc.
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6
Classification: Class I
Class I RecallJan 2025
Endo USA, Inc.
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6
Classification: Class I
Class I RecallJan 2025
Endo USA, Inc.
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containin
Classification: Class I