Akorn Sufentanil Injection Recall: Subpotent Drug Risk
Akorn recalls 2mL Sufentanil Citrate Injection due to subpotent drug levels at 30-month stability. This may affect medical use. Check NDC 17478-0050-02 for affected lots.
Lower-risk recall
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Contact the company
What happened, in plain English
Akorn is recalling a specific medical injection product because it may not contain enough active ingredient after 30 months of storage. This could lead to ineffective pain management during medical procedures. Read more at govinfonow.com/recall/35398-akorn-sufentanil-injection-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35398-akorn-sufentanil-injection-recall-subpotent-drug-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0460-2022
Cite this page
“Akorn Sufentanil Injection Recall: Subpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35398-akorn-sufentanil-injection-recall-subpotent-drug-risk. Based on FDA recall #D-0460-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0460-2022%22&limit=1).
Why it’s dangerous
The medication may have lower-than-stated drug concentration after 30 months of storage. This could result in less effective pain relief during procedures requiring precise dosing.
Who’s affected
Healthcare providers using this injection for pain management under medical supervision. Patients receiving this medication through a prescription are most at risk.
How to tell if you have this one
Check for the product name 'Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL)' on the label. Look for NDC 17478-0050-02 and lot number 031489A with expiration 03/31/2022.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Look for NDC 17478-0050-02 and lot number 031489A with expiration 03/31/2022.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall is due to potential lower drug concentration after 30 months, but the product is still safe for use within its expiration date if stored properly.
Similar recalls
Latest drug recalls
Keep exploring
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-0460-2022 (January 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0460-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.