The Recall Desk

FDA (Drugs) recall action 97364

PFIZER INC recalled 2 products on 2025-08-27

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-08-27
Critical
0
Units
65,370

Why these products were recalled

Lack of Assurance of Sterility.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Drugs)··2025-08-27

    Epinephrine injection vials recalled for lack of assurance of sterility

    Hospira Epinephrine Injection USP, 1 mg/10 mL, lots LY3681, LY4360 and LY4416, is recalled nationwide for lack of assurance of sterility. 49,620 vials are affected.

    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.
    Category
    Distribution
    0 states