Hikma Pharmaceuticals Usa recalls
Hikma Pharmaceuticals Usa appears in 20 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 20 |
|---|---|
| Published | 2020-01-22 to 2026-09-02 |
| By agency | FDA Drug (20) |
| By classification | Class II (16), Class I (2), Class III (2) |
| By status | terminated (15), ongoing (5) |
| Distribution named in notices | OH, PR, US |
Recalls
- 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, Manuf…
FDA Drug · Class II · 2026-09-02 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). - Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Be…
FDA Drug · Class II · 2026-05-06 · Hikma Pharmaceuticals Usa
Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. - Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
FDA Drug · Class II · 2025-08-06 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds - Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma…
FDA Drug · Class I · 2024-08-28 · Hikma Pharmaceuticals Usa
Reason: Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) - Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ND…
FDA Drug · Class II · 2024-03-27 · Hikma Pharmaceuticals Usa
Reason: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. - Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufac…
FDA Drug · Class II · 2023-05-24 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C. - Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distri…
FDA Drug · Class II · 2023-01-04 · Hikma Pharmaceuticals Usa
Reason: Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. - Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922
FDA Drug · Class II · 2022-08-17 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-…
FDA Drug · Class II · 2022-08-17 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922
FDA Drug · Class II · 2022-08-17 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724…
FDA Drug · Class II · 2022-08-17 · Hikma Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23…
FDA Drug · Class III · 2021-09-01 · Hikma Pharmaceuticals Usa
Reason: Labeling: Not elsewhere classified: Mislabeling - Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by
FDA Drug · Class II · 2020-12-23 · Hikma Pharmaceuticals Usa
Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial. - Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd.…
FDA Drug · Class II · 2020-11-25 · Hikma Pharmaceuticals Usa
Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial. - Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica,…
FDA Drug · Class II · 2020-09-02 · Hikma Pharmaceuticals Usa
Reason: Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. - Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Ge…
FDA Drug · Class II · 2020-06-24 · Hikma Pharmaceuticals Usa
Reason: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. - Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Ge…
FDA Drug · Class II · 2020-06-24 · Hikma Pharmaceuticals Usa
Reason: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. - methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA
FDA Drug · Class III · 2020-01-29 · Hikma Pharmaceuticals Usa
Reason: Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alco… - Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-2…
FDA Drug · Class I · 2020-01-22 · Hikma Pharmaceuticals Usa
Reason: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) - Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (ND…
FDA Drug · Class II · 2020-01-22 · Hikma Pharmaceuticals Usa
Reason: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)