CLASS II Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report
Sufentanil Citrate Injection, USP 100 mcg/ (50 mcg/mL) recalled by Akorn
Akorn is recalling Sufentanil Citrate Injection, USP 100 mcg/ (50 mcg/mL) for intravenous and epidural use, distributed nationwide in the US. The recall was initiated on 5 Jan 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0460-2022
- FDA event ID
- 89361
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2022
- FDA classified
- 27 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Jan 2022 | Recall initiated by company | |
| 19 Jan 2022 | Published in enforcement report | +14 days |
| 27 Jan 2022 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Which lots are affected?
Lot # 031489A, Expiration 03/31/2022
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Sufentanil recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sufentanil 300MCG/ML INJ in syringe Assurance Infusion recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Sufentanil 55.5 MCG/ML IN INJ in syringe Assurance Infusion recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Sufentanil 150MCG/ML INJ in syringe Assurance Infusion recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl recalled | Pharmedium Services | Particulate Matter | Nationwide |
| Drug | CLASS II | 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled | Pharmedium Services | Particulate Matter | Nationwide |