Quick Facts at a Glance
- Recall Date
- August 4, 2025
- Hazard Level
- HIGH
- Brands
- Epinephrine, Hospira, Pfizer
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Epinephrine, Hospira, Pfizer
- Product type
- Epinephrine Injection
- Model numbers
- Lot LY3681, LY4360, LY4416, Exp. 02/28/2026
- UPC codes
- 0409-4933, 0409-4933-11, 0409-4933-01, 0409-4933-05, 0409-4933-10
- Sizes
- 1 mg/10 mL (0.1 mg/mL)
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 4, 2025
Reported by FDA DRUG
August 27, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact PFIZER INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Epinephrine is used for emergency treatment of severe allergic reactions and other acute conditions. This recall concerns sterile integrity. The recall is nationwide and involves 49,620 vials.
Why This Is Dangerous
Lack of assurance of sterility means there could be contamination risk if used. No confirmed injuries in the notice.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
No reported injuries; potential risk to patients if contaminated vials are used, impacting hospital pharmacies and emergency responders.
Practical Guidance
How to identify if yours is affected
- Check NDC 0409-4933-05 on vial label
- Check Case NDC 0409-4933-10
- Verify Lot LY3681, LY4360, LY4416
Where to find product info
Pharmacy records, recall letters, FDA enforcement page
What timeline to expect
4-6 weeks for any potential refund or replacement processes through Pfizer/Hospira channels
If the manufacturer is unresponsive
- Escalate with hospital infection control
- Contact FDA MedWatch for adverse events
- Consult legal counsel if needed
How to prevent similar issues
- Verify sterility assurances in future shipments
- Rely on approved distributors
- Check NDCs and lot numbers before use
- Report adverse events promptly
Documentation advice
Keep recall letter, batch records, and supplier communications; photograph labels and lot numbers
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Product Details
Model numbers: Lot numbers LY3681, LY4360, LY4416. Expiration: 02/28/2026. Quantity: 49,620 vials. Distribution: United States, nationwide. Sold as Rx only Epinephrine Injection, USP 1 mg/10 mL (0.1 mg/mL). Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case NDC 0409-4933-10. Brand: Epinephrine; Generic: Epinephrine.
Reported Incidents
No injuries or incidents have been reported in the provided notice.
Key Facts
- 49,620 total vials recalled
- Rx only Epinephrine Injection, USP 1 mg/10 mL
- Lot LY3681, LY4360, LY4416
- NDC 0409-4933-05; Case NDC 0409-4933-10
- Active recall as of 2025-08-04; report date 2025-08-27
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Safety Guide
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