Quick answers
- What is Aminocaproic acid used for?
- The FDA-approved label (Aminocaproic Acid, Hikma Pharmaceuticals USA Inc., January 8, 2024) says: “Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Aminocaproic acid have a boxed warning?
- No. None of the 26 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Aminocaproic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aminocaproic acid been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Aminocaproic acid?
- 23 companies list prescription products of Aminocaproic acid in the FDA NDC Directory, including Vitruvias Therapeutics, Carnegie Pharmaceuticals LLC and Novadoz Pharmaceuticals LLC.
What Aminocaproic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt …
— FDA label: Aminocaproic Acid, Hikma Pharmaceuticals USA Inc., effective January 8, 2024. Read the full label on DailyMed →
The FDA has 26 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 26 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Solution · Injection, solution · Syrup |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 36 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| aminocaproic acid 0.25 g/mL solution | Generic | $0.5812 per mL |
| aminocaproic acid 0.25 g/mL syrup | Generic | $0.5812 per mL |
| aminocaproic acid 1000 mg tablet | Generic | $8.30 per tablet |
| aminocaproic acid 500 mg tablet | Generic | $2.48 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Vitruvias Therapeutics3 products
- Carnegie Pharmaceuticals LLC3 products
- Novadoz Pharmaceuticals LLC3 products
- Biocon Pharma Inc.3 products
- Medical Purchasing Solutions, LLC2 products
- Puracap Laboratories LLC dba Blu Pharmaceuticals2 products
- Hikma Pharmaceuticals USA Inc.2 products
- American Regent, Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Apozeal Pharmaceuticals Inc1 product
- Aurobindo Pharma Limited1 product
- American Health Packaging1 product
- Henry Schein, Inc.1 product
- Florida Pharmaceutical Products, LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- TruPharma, LLC1 product
- Civica, Inc.1 product
- Hospira, Inc.1 product
- Major Pharmaceuticals1 product
- Amneal Pharmaceuticals NY LLC1 product
- Amneal Pharmaceuticals LLC1 product
- BPI Labs LLC1 product
- Bryant Ranch Prepack1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA015197 AMICAR | Hikma | June 3, 1964 | 21, latest August 19, 2008 2008: Labeling · 2004: Labeling · 2004: Manufacturing (CMC) |
| NDA015230 AMICAR | Hikma | June 4, 1964 | 19, latest February 3, 2009 2009: Labeling · 2008: Labeling · 2004: Labeling |
Generic approvals (17)
- ANDA070010Hospira · March 9, 1987
- ANDA071192Luitpold · December 1, 1987
- ANDA209060Sunny · November 27, 2018
- ANDA212780Amneal · August 23, 2019
- ANDA212492Amneal · November 26, 2019
- ANDA212494Tp Anda Holdings · August 11, 2020
- ANDA212938Msn · November 6, 2020
- ANDA214140Carnegie · January 26, 2021
- ANDA213928Pharmobedient · February 12, 2021
- ANDA213825Ajenat Pharms · April 8, 2021
- ANDA215510Regcon Holdings · March 23, 2022
- ANDA213944Rising · September 14, 2022
- ANDA216804Aurobindo Pharma · September 26, 2022
- ANDA216464Annora Pharma · November 4, 2022
- ANDA213213Sunny · December 27, 2023
- ANDA215100Msn · September 26, 2024
- ANDA213216Pharmazone · May 19, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 24, 2026 · Class II · Ongoing · D-0794-2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc. — American Regent, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aminocaproic Acid, Hikma Pharmaceuticals USA Inc., effective January 8, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →