FDA recall record · openFDA

Endo USA, Inc.

11 FDA recalls on record (2024–2026) — 11 drug. 11 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. 5

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product 4

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ ( 1

Crystallization; identified as Buprenorphine free base 1

Recalls

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containi Class I 2024-11-18 Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 Class I 2024-11-18 Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed Class I 2024-12-20 Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 Class I 2024-11-18 Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containin Class I 2024-11-18 Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern Class II 2026-03-13 Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured Class III 2025-10-10 Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured Class III 2025-10-10 Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured Class III 2025-10-10 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by Class III 2025-09-05 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by Class III 2025-10-10

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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