Does Prasugrel have a boxed warning?

Yes. The FDA label for Effient has a boxed warning (“WARNING: BLEEDING RISK”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.

Is there a shortage of Prasugrel?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Prasugrel been recalled?

FDA enforcement reports list 5 recalls of products of this medicine; the newest started August 21, 2026 (Class II). A recall usually concerns specific lots, not every product.

11 companies list prescription products of Prasugrel in the FDA NDC Directory, including Apotex Corp., Unichem Pharmaceuticals (USA), Inc. and Panacea Biotec Limited.

Prasugrel (Effient): uses, warnings, recalls

Quick answers

What is Prasugrel used for?: The FDA-approved label (Effient, Cosette Pharmaceuticals, Inc., September 7, 2022) says: “Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Prasugrel have a boxed warning?: Yes. The FDA label for Effient has a boxed warning (“WARNING: BLEEDING RISK”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Prasugrel?: No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Prasugrel been recalled?: FDA enforcement reports list 5 recalls of products of this medicine; the newest started August 21, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Prasugrel?: 11 companies list prescription products of Prasugrel in the FDA NDC Directory, including Apotex Corp., Unichem Pharmaceuticals (USA), Inc. and Panacea Biotec Limited.

What Prasugrel is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI). …

— FDA label: Effient, Cosette Pharmaceuticals, Inc., effective September 7, 2022. Read the full label on DailyMed →

The FDA has 11 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.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Stroke

Related medical specialties

Neurology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: BLEEDING RISK. Read it on the full label →

11 of 11 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage forms	Tablet, film coated · Tablet, coated
Route	Oral
Prescription products	21 in the FDA NDC Directory
Brand names	Effient

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.

NADAC per unit for Prasugrel, by strength and form
Strength and form	Generic or brand	Pharmacies pay
prasugrel hydrochloride 10 mg tablet, film coated	Generic	$0.2557 per tablet
prasugrel hydrochloride 5 mg tablet, film coated	Generic	$0.2574 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.

Apotex Corp.3 products
Unichem Pharmaceuticals (USA), Inc.2 products
Panacea Biotec Limited2 products
Golden State Medical Supply, Inc.2 products
Amneal Pharmaceuticals LLC2 products
Aurobindo Pharma Limited2 products
Mylan Pharmaceuticals Inc.2 products
Accord Healthcare Inc.2 products
Cosette Pharmaceuticals, Inc.2 products
Bryant Ranch Prepack1 product
American Health Packaging1 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.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
NDA022307 EFFIENT	Cosette	July 10, 2009	13, latest December 22, 2020 2020: Labeling · 2019: Labeling · 2018: Labeling

Generic approvals (6)

ANDA205927Mylan · July 12, 2017
ANDA205888Aurobindo Pharma · October 16, 2017
ANDA205897Panacea · October 16, 2017
ANDA205987Accord Hlthcare · February 2, 2018
ANDA205913Amneal Pharms · June 19, 2018
ANDA213315Unichem · August 28, 2023

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

August 21, 2026 · Class II · Ongoing · D-0847-2026

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30. — Golden State Medical Supply Inc.
August 17, 2026 · Class II · Ongoing · D-0839-2026

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93. — Mylan Pharmaceuticals Inc
March 5, 2025 · Class II · Ongoing · D-0287-2025

Failed Dissolution Specifications

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 — Golden State Medical Supply Inc.
February 25, 2025 · Class II · Ongoing · D-0280-2025

Failed Dissolution Specifications - low dissolution results

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 — MYLAN PHARMACEUTICALS INC
October 18, 2019 · Class II · Terminated · D-0155-2020

Failed Dissolution Specification: Low out of specification dissolution results.

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93 — Mylan Pharmaceuticals 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

RxCUI (RxNorm)	855812, 855816, 855818, 855820
SPL set ID of the quoted label	69ea2d58-5353-4222-b61f-cab976fa7e5e
FDA labels (SPL)	11
FDA applications	NDA022307, 6 ANDA
Active ingredients (FDA)	PRASUGREL

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Effient, Cosette Pharmaceuticals, Inc., effective September 7, 2022; 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 →

Report an error → · Information for medicine makers

Prasugrel

Official FDA data, not advice

At a glance