Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured
Akorn recalls fentanyl injections with impurities exceeding safety limits. This may cause serious harm if used improperly. Stop using and contact your doctor immediately.
Stop using this now
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
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What happened, in plain English
Akorn is recalling fentanyl injections that tested with high impurity levels. Using these injections could cause serious harm due to unsafe chemical levels. Read more at govinfonow.com/recall/37218-akorn-fentanyl-injection-recall-impurities-risk-serious-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/37218-akorn-fentanyl-injection-recall-impurities-risk-serious-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-1258-2020
Cite this page
“Akorn Fentanyl Injection Recall: Impurities Risk Serious Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37218-akorn-fentanyl-injection-recall-impurities-risk-serious-harm. Based on FDA recall #D-1258-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1258-2020%22&limit=1).
Why it’s dangerous
The injections contain impurities at levels above the safe limit (4.1% vs. 3.0% maximum). This could lead to serious health effects if the medication is used as intended.
Who’s affected
Prescription holders of the specific fentanyl injection product with the listed lot number and expiration date. Patients using this medication under medical supervision are at risk.
How to tell if you have this one
Check for the product name 'Fentanyl Citrate Injection, USP', 100 mcg/2 mL, 10 ampules per carton, manufactured by Akorn, Inc. Look for lot number 081887A and expiration date 08/2021.
- Brand
Akorn- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled fentanyl injection product as it poses a serious health risk.
Questions people ask
Is this product safe to use?
No, the product has impurities exceeding safe limits and should not be used.
What should I do if I have this product?
Stop using it immediately and contact your doctor for guidance.
How can I check if I have the recalled product?
Look for the product name 'Fentanyl Citrate Injection, USP', 100 mcg/2 mL, 10 ampules per carton, manufactured by Akorn, Inc. with lot number 081887A and expiration date 08/2021.
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-1258-2020 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1258-2020 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-1258-2020 (March 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1258-2020 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.