CLASS III Drug recall · Reported 8 Apr 2020 · FDA Enforcement Report
Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL) recalled by Akorn
Akorn is recalling Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL), 10 Ampules per carton each), distributed nationwide in the US. The recall was initiated on 25 Mar 2020 and the FDA has classified it as Class III.
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-1258-2020
- FDA event ID
- 85239
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Mar 2020
- FDA classified
- 1 May 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 25 Mar 2020 | Recall initiated by company | |
| 8 Apr 2020 | Published in enforcement report | +14 days |
| 1 May 2020 | Classified by FDA | +23 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
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
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL), 10 Ampules per carton each) recalled?
Yes. Akorn recalled Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL), 10 Ampules per carton each) on 25 Mar 2020. The recall is Class III and its status is Terminated. Recall number D-1258-2020.
Why was it recalled?
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Which lots are affected?
Lot 081887A, EXP 08/2021
Where was it sold?
Distributed 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 005% (Scalp Solution) recalled by Akorn | 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 Fentanyl recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System | Alvogen | Packaging Defects | Nationwide |
| Drug | CLASS II | Fentanyl Citrate Injection, USP 100 mcg/ (50 mcg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Fentanyl Citrate Inj., USP 100 mcg Fentanyl recalled by PfizerFentanyl Citrate | Pfizer | Foreign Material | PR |
| Drug | CLASS II | fentaNYL Citrate Injection 50 mcg per mL recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injection, 50 mcg per mL recalled | PharMEDium Services | Sterility | Nationwide |