--- title: "Hikma Pharmaceuticals USA Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Hikma Pharmaceuticals USA Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/hikma-pharmaceuticals-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Hikma Pharmaceuticals USA Inc. recall records **5** reported ongoing 11 records in this archive. Latest source date Aug 24, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 24, 2026 FDA drug enforcement ### [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, I...](https://isitonrecall.com/recall/fda-drug-d-0831-2026-ramipril-capsules-usp-10-mg-packaged-in-a-100-capsules-ndc-76282-673-01-and-b-500-capsules-ndc-76282/) Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0831-2026%22) Apr 7, 2026 FDA drug enforcement ### [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., Berkeley Heights, NJ 07922, NDC 0054-028...](https://isitonrecall.com/recall/fda-drug-d-0526-2026-alendronate-sodium-oral-solution-70-mg-75-ml-75-ml-rx-only-4-x-75-ml-single-dose-bottles-distr-by-hi/) This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. Class II Reported ongoing Distribution: US Nationwide. [Official source for Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Dis...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0526-2026%22) Jul 22, 2025 FDA drug enforcement ### [Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25](https://isitonrecall.com/recall/fda-drug-d-0551-2025-lorazepam-injection-usp-2-mg-ml-25-x-1ml-vials-carton-rx-only-manufactured-by-hikma-berkeley-heights/) Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkele...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0551-2025%22) Jul 8, 2024 FDA drug enforcement ### [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 Farmaceutica (Portugal), SA, distribu...](https://isitonrecall.com/recall/fda-drug-d-0635-2024-acetaminophen-injection-1-000-mg-per-100-ml-10-mg-ml-100-ml-single-dose-bags-for-intravenous-use-onl/) 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) Class I Reported ongoing Distribution: OH and PR [Official source for Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0635-2024%22) Mar 12, 2024 FDA drug enforcement ### [Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01](https://isitonrecall.com/recall/fda-drug-d-0392-2024-infumorph-preservative-free-morphine-sulfate-sterile-solution-20-ml-ampul-rx-only-manufactured-by-hi/) The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactur...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0392-2024%22) May 11, 2023 FDA drug enforcement ### [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, Manufactured by West-Ward, Eatontown, NJ 07724.](https://isitonrecall.com/recall/fda-drug-d-0574-2023-lorazepam-injection-usp-2mg-ml-1-ml-vial-ndc-0641-6044-01-packaged-in-25-x-1-ml-vials-per-carton-ndc/) Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C. Class II Reported terminated Distribution: Nationwide in the USA and Puerto Rico [Official source for Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per c...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0574-2023%22) Dec 16, 2022 FDA drug enforcement ### [Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07...](https://isitonrecall.com/recall/fda-drug-d-0090-2023-ganciclovir-for-injection-usp-500mg-per-vial-packaged-in-a-10-count-carton-rx-only-mfd-by-thymoorgan/) Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. Class II Reported terminated Distribution: USA Nationwide [Official source for Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0090-2023%22) Jul 11, 2022 FDA drug enforcement ### [Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01](https://isitonrecall.com/recall/fda-drug-d-1307-2022-lorazepam-injection-usp-2mg-ml-1-ml-vial-25-vials-per-carton-rx-only-manufactured-by-west-ward-eaton/) Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-W...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1307-2022%22) Jul 11, 2022 FDA drug enforcement ### [Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# ...](https://isitonrecall.com/recall/fda-drug-d-1308-2022-ativan-injection-lorazepam-injection-usp-2mg-ml-1-ml-vial-25-vials-per-carton-rx-only-manufactured-b/) Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Man...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1308-2022%22) Jul 11, 2022 FDA drug enforcement ### [Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-60...](https://isitonrecall.com/recall/fda-drug-d-1309-2022-lorazepam-injection-usp-2mg-ml-1-ml-vial-25-vial-per-carton-rx-only-novaplus-manufactured-by-hikma-b/) Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1309-2022%22) Jul 11, 2022 FDA drug enforcement ### [Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 06...](https://isitonrecall.com/recall/fda-drug-d-1310-2022-lorazepam-injection-usp-4mg-ml-1-ml-vial-25-vial-per-carton-rx-only-novaplus-manufactured-by-hikma-b/) Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1310-2022%22) ## Reasons in these listed records - Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). - This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. - Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds - 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) These examples come from this result page and are not a ranking of every recall reason. ## Checking Hikma Pharmaceuticals USA Inc. ### Is there a recall on hikma pharmaceuticals usa inc. right now? This archive contains 11 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Hikma Pharmaceuticals USA Inc.](https://isitonrecall.com/check/?q=Hikma%20Pharmaceuticals%20USA%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)