Use caution Drug recall · FDA · Published August 6, 2019

Akorn Recalls Eptifibatide Injection Due to Impurity Issues

Akorn, Inc. recalls specific lots of Eptifibatide Injection vials due to out-of-specification impurities. Check lot numbers and expiration dates for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1839-2019Drug Akorn ›

Use caution until it’s fixed

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Take action

Contact the company

Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn, Inc. is recalling one lot each of Eptifibatide Injection, 75 mg/100 mL, because the product failed impurity specifications for D-aspartic acid. The recall affects 4,085 vials distributed nationwide in the U.S. No specific remedy or action steps are listed in the provided record. Read more at govinfonow.com/recall/38195-akorn-recalls-eptifibatide-injection-due-to-impurity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/38195-akorn-recalls-eptifibatide-injection-due-to-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-1839-2019

Cite this page

“Akorn Recalls Eptifibatide Injection Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38195-akorn-recalls-eptifibatide-injection-due-to-impurity-issues. Based on FDA recall #D-1839-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1839-2019%22&limit=1).

The FDA announced on August 6, 2019, that Akorn, Inc. voluntarily recalled Eptifibatide Injection vials due to out-of-specification impurities. The recall affects 4,085 units distributed nationwide.

How to tell if you have it

Brand: Akorn
Product: Eptifibatide Injection Vial
Strength/Volume: 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial
NDC: 17478-903-90
Lot Codes: 091287A, 091377A
Expiration Date: 9/19

The hazard

The recall is due to failed impurity specifications for the known impurity D-aspartic acid. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Akorn, Inc. has had 64 other recalls on record since August 5, 2014. Other recent recalls of similar products include Fresenius Kabi Epinephrine Injection Recall (May 14, 2026), Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (December 30, 2025), and Ascend Laboratories recalls Dabigatran etexilate capsules due to impurity risks (June 30, 2026).

How to tell if you have this one

Look for single-use vials labeled 'Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL' manufactured by Akorn, Inc. in Lake Forest, IL. Check the NDC number 17478-903-90 and lot numbers 091287A or 091377A with an expiration date of 9/19.

Brand
Akorn
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Nationwide in the U.S.

Recall number	Product, codes & lots	Quantity
D-1839-2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.; Lot #s: 091287A, 091377A, Exp. 9/19.	4085 vials
D-1840-2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.; Lot #: 101107A, Exp. 10/19.	648 vials
D-1841-2019	Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.; Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.	8187 vials

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your vials match the recalled lot numbers 091287A or 091377A.
Contact Healthcare Provider
Consult with a healthcare professional regarding the status of this medication, as no specific remedy is provided in the record.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

Aug 6, 2019Firm started the recall
Aug 23, 2019FDA classified it Class III
Sep 4, 2019Published in FDA’s Enforcement Report
Jul 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/38195-akorn-recalls-eptifibatide-injection-due-to-impurity-issues">Akorn Recalls Eptifibatide Injection Due to Impurity Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1839-2019 (August 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1839-2019 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.