--- title: "AuroMedics Pharma LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search AuroMedics Pharma LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/auromedics-pharma-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # AuroMedics Pharma LLC recall records **1** reported ongoing 5 records in this archive. Latest source date Sep 30, 2022. 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 Sep 30, 2022 FDA drug enforcement ### [Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. M...](https://isitonrecall.com/recall/fda-drug-d-0020-2023-fondaparinux-sodium-injection-usp-7-5-mg-per-0-6-ml-single-dose-prefilled-syringe-distributed-by-aur/) Subpotent Drug: Out of specification for assay Class II Reported terminated Distribution: Nationwide in the USA [Official source for Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distribute...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0020-2023%22) Sep 26, 2022 FDA drug enforcement ### [Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Mad...](https://isitonrecall.com/recall/fda-drug-d-0013-2023-acyclovir-sodium-injection-500mg-10ml-50mg-ml-10-ml-single-dose-vial-rx-only-distributed-by-auromedi/) Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. Class II Reported completed Distribution: Nationwide in the USA [Official source for Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0013-2023%22) Sep 26, 2022 FDA drug enforcement ### [Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 5515...](https://isitonrecall.com/recall/fda-drug-d-1551-2022-tranexamic-acid-injection-usp-1000mg-per-10-ml-100mg-ml-10ml-single-dose-vial-rx-only-distributed-by/) Presence of Particulate Matter: Piece of metal found in a vial Class III Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Dis...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1551-2022%22) Jan 28, 2022 FDA company announcement ### [Auromedics: Polymyxin B for Injection USP, 500,000 Units/Vial](https://isitonrecall.com/recall/fdapress-3f304fb4b80ef127-auromedics-polymyxin-b-for-injection-usp-500-000-units-vial/) Presence of Particulate Matter Not supplied Reported terminated Distribution: Not supplied [Official source for Auromedics: Polymyxin B for Injection USP, 500,000 Units/Vial](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial) Jan 26, 2022 FDA drug enforcement ### [Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 0852...](https://isitonrecall.com/recall/fda-drug-d-0556-2022-polymyxin-b-for-injection-usp-500-000-units-per-vial-10-ml-vials-packaged-in-10-vials-per-carton-ste/) Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot Class I Reported terminated Distribution: Nationwide in the US [Official source for Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per cart...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0556-2022%22) ## Reasons in these listed records - Subpotent Drug: Out of specification for assay - Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. - Presence of Particulate Matter: Piece of metal found in a vial - Presence of Particulate Matter These examples come from this result page and are not a ranking of every recall reason. ## Checking AuroMedics Pharma LLC ### Is there a recall on auromedics pharma llc right now? This archive contains 5 records, including 1 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 AuroMedics Pharma LLC](https://isitonrecall.com/check/?q=AuroMedics%20Pharma%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)