Hospira recalls 49,620 vials of Epinephrine Injection, distributed nationwide in the United States. The recall, active since August 4, 2025, targets vials with NDC 0409-4933-05 and case NDC 0409-4933-10. The hazard is lack of assurance of sterility. Health professionals should stop using the product and contact Pfizer or a healthcare provider for guidance.
Lack of Assurance of Sterility.
Consumers and healthcare providers should stop using this product immediately. Contact PFIZER INC or your healthcare provider for guidance. Notification method: Letter
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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.
Lack of assurance of sterility means there could be contamination risk if used. No confirmed injuries in the notice.
This recall is not described as part of a broader industry pattern.
No reported injuries; potential risk to patients if contaminated vials are used, impacting hospital pharmacies and emergency responders.
Pharmacy records, recall letters, FDA enforcement page
4-6 weeks for any potential refund or replacement processes through Pfizer/Hospira channels
Keep recall letter, batch records, and supplier communications; photograph labels and lot numbers
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.
No injuries or incidents have been reported in the provided notice.
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