Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. appears in FDA public data with 20 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 64 FDA inspections, and 4 compliance actions on record. Its most recent recall (D-0831-2026, Class II) was initiated on Aug 24, 2026. Its most recent FDA inspection ended on Jul 13, 2026 (Voluntary Action Indicated (VAI)).
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Summary
- Total Recalls
- 20 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 64
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0831-2026 | Class II | Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (ND | Aug 24, 2026 |
| D-0526-2026 | Class II | Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. | Apr 7, 2026 |
| D-0551-2025 | Class II | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley | Jul 22, 2025 |
| D-0635-2024 | Class I | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Us | Jul 8, 2024 |
| D-0392-2024 | Class II | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured | Mar 12, 2024 |
| D-0574-2023 | Class II | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per cart | May 11, 2023 |
| D-0090-2023 | Class II | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THY | Dec 16, 2022 |
| D-1310-2022 | Class II | Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by | Jul 11, 2022 |
| D-1307-2022 | Class II | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-War | Jul 11, 2022 |
| D-1309-2022 | Class II | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by | Jul 11, 2022 |
| D-1308-2022 | Class II | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manuf | Jul 11, 2022 |
| D-0771-2021 | Class III | Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Th | Aug 5, 2021 |
| D-0169-2021 | Class II | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West- | Dec 7, 2020 |
| D-0101-2021 | Class II | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For | Nov 3, 2020 |
| D-1533-2020 | Class II | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Onl | Aug 14, 2020 |
| D-1309-2020 | Class II | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie | Jun 11, 2020 |
| D-1308-2020 | Class II | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie | Jun 11, 2020 |
| D-0801-2020 | Class III | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACE | Jan 14, 2020 |
| D-0658-2020 | Class II | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC | Dec 17, 2019 |
| D-0864-2020 | Class I | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01 | Dec 17, 2019 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 13, 2026 | Berkeley Heights, NJ | Drugs | Voluntary Action Indicated (VAI) | 3017452050 |
| May 13, 2026 | Cherry Hill, NJ | Drugs | No Action Indicated (NAI) | 2220525 |
| Apr 30, 2026 | Columbus, OH | Drugs | No Action Indicated (NAI) | 1510690 |
| Jan 17, 2025 | Columbus, OH | Drugs | No Action Indicated (NAI) | 1510690 |
| Jul 23, 2024 | Columbus, OH | Devices | No Action Indicated (NAI) | 1510690 |
| Jun 12, 2024 | Cherry Hill, NJ | Drugs | Voluntary Action Indicated (VAI) | 2220525 |
| Nov 3, 2023 | Cherry Hill, NJ | Drugs | Voluntary Action Indicated (VAI) | 2220525 |
| Sep 29, 2023 | Bedford, OH | Drugs | Voluntary Action Indicated (VAI) | 3012279857 |
| Dec 15, 2022 | Bedford, OH | Drugs | Voluntary Action Indicated (VAI) | 3012279857 |
| Sep 15, 2022 | Columbus, OH | Drugs | No Action Indicated (NAI) | 1510690 |
| Jul 7, 2022 | Cherry Hill, NJ | Drugs | No Action Indicated (NAI) | 2220525 |
| Feb 7, 2022 | Bedford, OH | Drugs | Voluntary Action Indicated (VAI) | 3012279857 |
| Jan 31, 2020 | Bedford, OH | Drugs | Voluntary Action Indicated (VAI) | 3012279857 |
| Nov 22, 2019 | Columbus, OH | Drugs | No Action Indicated (NAI) | 1510690 |
| Sep 10, 2019 | Cherry Hill, NJ | Drugs | Voluntary Action Indicated (VAI) | 2220525 |
| Apr 16, 2019 | Columbus, OH | Drugs | No Action Indicated (NAI) | 1510690 |
| Feb 1, 2019 | Eatontown, NJ | Drugs | No Action Indicated (NAI) | 2250102 |
| Sep 14, 2018 | Cherry Hill, NJ | Drugs | No Action Indicated (NAI) | 2220525 |
| Apr 18, 2018 | Columbus, OH | Drugs | Voluntary Action Indicated (VAI) | 1510690 |
| Apr 13, 2018 | Eatontown, NJ | Drugs | No Action Indicated (NAI) | 2250102 |