GlucaGen Glucagon Injection Recalled for Temperature Control Deviations
GlucaGen (glucagon) injection vials are being recalled due to temperature abuse during manufacturing that may have compromised product stability. The 187 vials were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a critical emergency injection medication due to temperature-control deviations during manufacturing. While no reported illnesses are stated in the source, temperature abuse of glucagon—used for severe hypoglycemia—presents a risk-of-harm where drug efficacy in emergency situations may be compromised.
Plain-English summary
GlucaGen (glucagon) for injection, 1 mg per vial, is a prescription medication in a single-dose kit form. The product (NDC 0597-0260-10) is manufactured for Boehringer Mannheim and distributed by McKesson Medical-Surgical Inc. A total of 187 vials have been recalled and were distributed nationwide throughout the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing. Specifically, the product experienced temperature abuse, which may have affected the product's stability and integrity.
McKesson Medical-Surgical is unable to identify the specific lot number for each recipient. Customers should refer to the recall notification letters they received, which include the distribution dates and shipping information for their affected product.
Patients and healthcare providers who have received this product should contact McKesson Medical-Surgical Inc. or their local pharmacy for return and replacement instructions.
The recalled product
- Product
- GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 187
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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