FDA recall record

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial recall — FDA D-0723-2026

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

Class IIclassification
D-0723-2026official record ID
Jul 8, 2026report date

Recall record at a glance

Official recordD-0723-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmLupin Pharmaceuticals Inc.
Report dateJul 8, 2026
Recall initiation dateJun 23, 2026
Quantity64,894 units
LocationNaples, FL, United States

Official 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

Why the product was recalled

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

Distribution information

Nationwide within the U.S.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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