The Recall Desk
HighFDA (Drugs)·D-0590-2025·Announced 2025-08-27

Epinephrine Injection Vials Recalled Over Sterility Assurance Issue

Pfizer is recalling 49,620 vials of Epinephrine Injection nationwide due to lack of sterility assurance. Affected lots are LY3681, LY4360, and LY4416, expiring 02/28/2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for lack of sterility assurance in an injectable medication. Epinephrine is a high-risk-of-harm product (critical emergency medication), and no adverse events are reported in the source. The potential for microbial contamination in an injectable combined with the Class II classification warrants High severity.

Plain-English summary

Pfizer Inc. is recalling 49,620 vials of Epinephrine Injection, USP, 1mg/10mL nationwide due to lack of sterility assurance. The recall affects lots LY3681, LY4360, and LY4416, all expiring 02/28/2026.

Epinephrine is a critical emergency medication used to treat severe allergic reactions and anaphylaxis. Healthcare facilities and pharmacies that have received affected vials should cease dispensing them immediately and contact Pfizer for instructions on product returns or replacement.

The recalled product

Product
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.
Manufacturer
PFIZER INC
Category
Drug — Injectable / Emergency Medication
Hazard
  • contamination-risk
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: LY3681
  • LY4360
  • LY4416
  • Exp. 02/28/2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same category