Hikma Pharmaceuticals recalls
8 official recalls and safety alerts involving Hikma Pharmaceuticals since 2022-08, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Hikma Pharmaceuticals or the relevant agency.
- 2026-09-02
USHikma Pharmaceuticals USA INC. 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…
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- 2026-05-06
- US
Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA…
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- 2025-08-06
- US
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC#…
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- 2024-08-28
- US
Hikma Pharmaceuticals USA Inc. recalls Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured…
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)
- 2024-03-27
- US
Hikma Pharmaceuticals USA Inc. recalls Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ…
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- 2023-05-24
- US
Hikma Pharmaceuticals USA Inc. recalls 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…
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
- 2023-01-04
- US
Hikma Pharmaceuticals USA Inc. recalls Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH,…
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
- 2022-08-17
- US
Hikma Pharmaceuticals USA Inc. recalls Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward…
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.