Hikma Pharmaceuticals USA Inc.: 19 recalls on record

Recalls filed with 1 agency: FDA (19).

First recall on record: January 22, 2020. Most recent: September 2, 2026.

Risk classification: Class I: 2 · Class II: 16 · Class III: 1

Most recent recalls

DateAgencyProduct
September 2, 2026FDARamipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 C…D-0831-2026
May 6, 2026FDAAlendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bott…D-0526-2026
August 6, 2025FDALorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikm…D-0551-2025
August 28, 2024FDAAcetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Int…D-0635-2024
March 27, 2024FDAInfumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Ma…D-0392-2024
May 24, 2023FDALorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Via…D-0574-2023
January 4, 2023FDAGanciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, M…D-0090-2023
August 17, 2022FDALorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured …D-1307-2022
August 17, 2022FDALorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manu…D-1309-2022
August 17, 2022FDAAtivan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX …D-1308-2022
August 17, 2022FDALorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manu…D-1310-2022
December 23, 2020FDASodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd…D-0169-2021
November 25, 2020FDASodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative…D-0101-2021
September 2, 2020FDABuprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use O…D-1533-2020
June 24, 2020FDAIrinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorga…D-1309-2020
June 24, 2020FDAIrinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorga…D-1308-2020
January 29, 2020FDAmethylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HI…D-0801-2020
January 22, 2020FDAKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose…D-0658-2020
January 22, 2020FDAKetorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0…D-0864-2020

Questions about this company

How many recalls does Hikma Pharmaceuticals USA Inc. have?
Recalert has 19 U.S. recalls on record for Hikma Pharmaceuticals USA Inc., published between January 22, 2020 and September 2, 2026.
What was the most recent Hikma Pharmaceuticals USA Inc. recall?
FDA recall D-0831-2026, published September 2, 2026: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33…
Which agencies have handled Hikma Pharmaceuticals USA Inc. recalls?
Hikma Pharmaceuticals USA Inc. appears as the recalling firm in recalls from: FDA (19).

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