FDA recall D-0723-2026

Lupin Pharmaceuticals Inc. · Class II · drug

Product

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 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.

Key facts

Status
Ongoing
Initiation date
2026-06-23
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0723-2026