Home / Recalls / PFIZER INC / D-0590-2025

D-0590-2025 Class II Ongoing

Recalled by PFIZER INC — New York, NY

Recall Details

Product Type
Drugs
Report Date
August 27, 2025
Initiation Date
August 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49,620 vials

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility.

Distribution Pattern

U.S. Nationwide

Code Information

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

Other recalls by PFIZER INC

  • D-0591-2025 Class II — Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx o (August 4, 2025)
  • D-0575-2025 Class II — Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, (July 29, 2025)
  • D-0545-2025 Class II — Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units pe (July 10, 2025)
  • D-0544-2025 Class II — Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per (July 10, 2025)
  • D-0489-2025 Class II — DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial (May 28, 2025)
  • D-0565-2024 Class II — Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C (May 20, 2024)
  • D-0564-2024 Class II — Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpujec (May 20, 2024)
  • D-0261-2024 Class I — Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop via (December 21, 2023)
  • D-0234-2024 Class I — 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Gla (December 21, 2023)
  • D-0235-2024 Class I — Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJE (December 21, 2023)