The Recall Desk
HighFDA (Drugs)·D-1012-2022·Announced 2022-06-15

Prescription EpiPen auto-injectors recalled for temperature-abuse manufacturing defect

McKesson Medical-Surgical is recalling EpiPen Jr epinephrine auto-injectors nationwide due to temperature exposure during manufacturing that may degrade medication potency.

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 a Class II recall involving a risk-of-harm product (life-critical emergency medication) where no illnesses or injuries have been reported. Temperature-abused epinephrine may have reduced potency and could fail to treat anaphylaxis, a life-threatening emergency.

Plain-English summary

EpiPen Jr (epinephrine injection, USP) 0.15 mg auto-injectors in 2-count cartons are being recalled nationwide. The recall was initiated due to cGMP deviations, specifically temperature abuse during manufacturing and distribution. McKesson Medical-Surgical Inc. is coordinating the recall on behalf of the manufacturer.

Epinephrine auto-injectors are emergency medications used to treat severe allergic reactions and anaphylaxis. Temperature exposure can degrade epinephrine potency, potentially compromising the effectiveness of the medication when needed.

Patients and healthcare providers who have received this product should check recall notifications for distribution dates and lot number information. Do not use recalled auto-injectors. Contact your healthcare provider for replacement medication and to ensure you have a functional emergency anaphylaxis treatment plan in place.

The recalled product

Product
EPIPEN (EPINEPHRINE)
Brand
EPIPEN
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Emergency Medication
Hazard
  • temperature-abuse
  • potency-loss

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · EPIPEN

Same category