Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe
Summary
The FDA issued a recall for Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per by Lupin Pharmaceuticals Inc.. Reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing..
Details
Source
Drug Recall
External ID
N/A
Action Date
2026-07-08
Status
Ongoing
Category
drug
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
Lot/Code Info: 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.
Quantity Affected: 64,894 units
Reason for Recall
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Distribution
Nationwide within the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-23
Company
Naples, FL
Context & Analysis
This is a unclassified recall.
This was one of 39 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 51 FDA actions in our database, including 51 recalls.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 51 FDA actions in our database, including 51 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "N/A" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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