Akorn, Inc. recalls Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only,
Akorn recalls Eptifibatide injection vials with impurity D-aspartic acid that may cause safety issues. Affected lots: 091287A, 091377A (expiring 9/19).
Recall notice
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Eptifibatide injection vials due to impurities that could pose safety risks. This recall affects specific production lots that expire in September 2019. Read more at govinfonow.com/recall/38195-akorn-eptifibatide-injection-recall-impurity-risk-in-iv-medication.
Source Summary by GovInfoNow · govinfonow.com/recall/38195-akorn-eptifibatide-injection-recall-impurity-risk-in-iv-medication · Updated October 5, 2026 · FDA enforcement record: FDA #D-1839-2019
Cite this page
“Akorn Eptifibatide Injection Recall: Impurity Risk in IV Medication.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38195-akorn-eptifibatide-injection-recall-impurity-risk-in-iv-medication. Based on FDA recall #D-1839-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1839-2019%22&limit=1).
Why it’s dangerous
The medication contains an impurity called D-aspartic acid that failed quality tests. This impurity could potentially cause safety issues when administered intravenously.
Who’s affected
Healthcare professionals using this medication for intravenous treatment are affected. Patients receiving this medication under a prescription are at risk if they use the recalled vials.
How to tell if you have this one
Check for vials labeled 'Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only'. The affected lots are 091287A and 091377A, expiring September 19, 2019.
- Brand
Akorn- Category
Drug
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 |
What to do — step by step
Check Vial Lot Number
Look for the lot number on the vial label, which should be 091287A or 091377A.
Questions people ask
What is the specific impurity in the recalled medication?
The medication contains D-aspartic acid, which failed quality specifications.
How can I tell if I have the recalled product?
Check the vial label for lot numbers 091287A or 091377A, expiring September 19, 2019.
What should I do if I have the recalled vial?
The recall record does not specify a remedy, so contact Akorn directly for guidance.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1839-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1839-2019 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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 qwen3:4b on October 5, 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.