--- title: "Hikma Injectables USA Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Hikma Injectables 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-injectables-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Hikma Injectables USA Inc recall records **0** reported ongoing 4 records in this archive. Latest source date Dec 19, 2024. 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 Dec 19, 2024 FDA drug enforcement ### [ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded...](https://isitonrecall.com/recall/fda-drug-d-0173-2025-ketamine-inj-50-mg-per-1-ml-rx-only-1-ml-fill-in-a-3ml-pre-filled-syringe-for-iv-or-im-use-hikma-inj/) Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. Class II Reported terminated Distribution: Nationwide in the USA [Official source for ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0173-2025%22) Dec 19, 2024 FDA drug enforcement ### [phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25](https://isitonrecall.com/recall/fda-drug-d-0174-2025-phenylephrine-in-0-9-sodium-chloride-inj-1mg-per-10-ml-100-mcg-ml-rx-only-hikma-injectables-usa-inc/) Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. Class II Reported terminated Distribution: Nationwide in the USA [Official source for phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0174-2025%22) Apr 30, 2024 FDA drug enforcement ### [Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, N...](https://isitonrecall.com/recall/fda-drug-d-0480-2024-fentanyl-1000mcg-100ml-10mcg-ml-in-0-9-sodium-chloride-injection-packaged-in-100ml-bags-rx-only-comp/) Labeling: Wrong Barcode Class III Reported completed Distribution: Nationwide within the United States [Official source for Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx o...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0480-2024%22) Apr 29, 2024 FDA drug enforcement ### [Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25](https://isitonrecall.com/recall/fda-drug-d-0508-2024-phenylephrine-in-0-9-sodium-chloride-injection-preservative-free-100mcg-ml-5ml-syringe-rx-only-hikma/) Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Class I Reported completed Distribution: CO, GA, PA, SD, WA [Official source for Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0508-2024%22) ## Reasons in these listed records - Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. - Labeling: Wrong Barcode - Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. These examples come from this result page and are not a ranking of every recall reason. ## Checking Hikma Injectables USA Inc ### Is there a recall on hikma injectables usa inc right now? This archive contains 4 records, including 0 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 Injectables USA Inc](https://isitonrecall.com/check/?q=Hikma%20Injectables%20USA%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)