Recall Ledger

Glucagon Emergency Kit for Low Blood Sugar recall (Lupin Pharmaceuticals Inc.)

DrugClass IIOngoing

Summary: Lupin Pharmaceuticals Inc. is recalling 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. Reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

What is being recalled

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

Why

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Nationwide within the U.S.

How to tell if yours is affected

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.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0723-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 23, 2026
ReportedJuly 8, 2026
CompanyLupin Pharmaceuticals Inc.
Company locationNaples, FL, United States
Initiated byVoluntary: Firm initiated
Quantity64,894 units

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