CLASS II Drug recall · Reported 12 Aug 2020 · FDA Enforcement Report
Fentanyl Citrate Inj., USP 100 mcg Fentanyl recalled by Pfizer
Pfizer is recalling Fentanyl Citrate Inj., USP 100 mcg Fentanyl/ (50 mcg/mL) Single-dose Fliptop Vials, distributed in Puerto Rico. The recall was initiated on 20 Jul 2020 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-1446-2020
- FDA event ID
- 86074
- Recalling firm
- Pfizer, New York, NY
- Brand
- Fentanyl Citrate
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2020
- FDA classified
- 4 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 20 Jul 2020 | Recall initiated by company | |
| 4 Aug 2020 | Classified by FDA | +15 days |
| 12 Aug 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Where it was distributed
United States including Puerto Rico
Questions about this recall
Is Fentanyl Citrate Inj., USP 100 mcg Fentanyl/ (50 mcg/mL) Single-dose Fliptop Vials recalled?
Yes. Pfizer recalled Fentanyl Citrate Inj., USP 100 mcg Fentanyl/ (50 mcg/mL) Single-dose Fliptop Vials on 20 Jul 2020. The recall is Class II and its status is Terminated. Recall number D-1446-2020.
Why was it recalled?
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Which lots are affected?
Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
Where was it sold?
United States including Puerto Rico
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 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 Pfizer
All 126| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ 1 mg/mL) recalled by PFIZER | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | 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 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 |
| Drug | CLASS III | Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |