Glucagon Kit
FDA Recall NDC 70748-311
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glucagon (NDC 70748-311). A significant event, classified as Class II, was initiated on Jun 23, 2026 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Jun 23, 2026
Jul 08, 2026
64,894 units
Recall Profile & Regulatory Data
Event ID
99296
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S.
Product Description
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01
Batch or Lot Expiration Information
Lot# Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.
Affected Packages Involved in this Recall
70748-311-01Product
70748-309-01Product
70748-310-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
