Pfizer's Class II Recall for Epinephrine

Pfizer Inc. has voluntarily initiated a Class II recall of Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL) supplied in vials and distributed by its Hospira division. The recall affects 49 620 vials nationwide across the United States. The impacted products, identified under lot numbers LY3681, LY4360, and LY4416 with an expiration date of February 28, 2026, were distributed under NDC codes 0409-4933-05 (vial label) and 0409-4933-10 (case). Notifications of the recall were sent to consignees by letter, and no public press release has been issued at this time.

The US Food & Drug Administration (FDA) classified this action as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences, with the likelihood of severe harm considered remote. The recall was initiated following concerns over a lack of assurance of sterility—a significant issue given the injectable route of administration and the drug’s role in acute medical care. The recall remains ongoing as of the FDA’s August 2025 update.

Epinephrine injection is a critical adrenergic agonist used in emergency treatment of anaphylaxis, cardiac arrest, and for severe asthma or bronchospasm unresponsive to initial therapy. It is also employed in certain clinical settings for hypotension associated with septic shock. Pharmacists should carefully review inventory to identify and remove affected lots, given the importance of ensuring sterility in life-saving injectable medications.