Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured
Akorn recalls fentanyl injections with impurities exceeding safety limits. This could lead to harmful effects if used. Check your product details to see if you're affected.
Lower-risk recall
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling fentanyl injections that may have impurities beyond safe levels. Using these products could pose health risks due to the impurities. Read more at govinfonow.com/recall/38883-akorn-fentanyl-injection-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/38883-akorn-fentanyl-injection-recall-impurities-may-cause-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-1241-2019
Cite this page
“Akorn Fentanyl Injection Recall: Impurities May Cause Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38883-akorn-fentanyl-injection-recall-impurities-may-cause-harm. Based on FDA recall #D-1241-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1241-2019%22&limit=1).
Why it’s dangerous
The fentanyl injections failed stability testing, showing impurities at 4.0% instead of the safe limit of 3.0%. This could lead to harmful effects if used.
Who’s affected
Prescription users of fentanyl injections with the specific lot number and expiration date. Healthcare providers and patients who have this product are most at risk.
How to tell if you have this one
Check for the lot number 011198 and expiration date 01/22 on the packaging. The product is a fentanyl injection with 100 mcg/2 mL, 25 ampules per carton.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 011198 and expiration date 01/22 on the packaging.
Questions people ask
Is this product safe to use?
The product has failed stability testing and may have impurities beyond safe limits, so it is not safe to use.
What should I do if I have this product?
The official recall notice does not specify a remedy, so check with your healthcare provider or the manufacturer for guidance.
How can I tell if I have the recalled product?
Look for the lot number 011198 and expiration date 01/22 on the packaging. The product is a fentanyl injection with 100 mcg/2 mL, 25 ampules per carton.
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-1241-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1241-2019 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-1241-2019 (April 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1241-2019 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.