CLASS II ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled
Pfizer is recalling Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL), distributed nationwide in the US. The recall was initiated on 4 Aug 2025 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-0590-2025
- FDA event ID
- 97364
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Aug 2025
- FDA classified
- 18 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 4 Aug 2025 | Recall initiated by company | |
| 18 Aug 2025 | Classified by FDA | +14 days |
| 27 Aug 2025 | Published in enforcement report | +9 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Where was it sold?
U.S. Nationwide
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.
Other products in this recall event
1 other product · FDA event 97364| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
More recalls from Pfizer
All 126| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | 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 |
| Drug | CLASS II | DOBUTamine Injection, USP, 250 mg recalled by PfizerDobutamine | Pfizer | Other | Nationwide |