Lupin Recalls 64,894 Glucagon Emergency Kits Over Syringe Force Defect

Lupin Pharmaceuticals Inc. has voluntarily recalled 64,894 units of its Glucagon Emergency Kit for Low Blood Sugar after the product failed a Gliding Force functionality test during long-term stability testing. The kit is used to treat severe hypoglycemia and relies on proper syringe function to deliver a life-saving dose quickly.

What Products Are Being Recalled?

The recall covers the Glucagon Emergency Kit for Low Blood Sugar, which includes Glucagon for Injection USP, 1mg per vial, and a Diluent for Glucagon supplied with a 1 mL syringe. The product is available by prescription only under NDC 70748-311-01. It was manufactured by Lupin Limited in Nagpur, India, and manufactured for Lupin Pharmaceuticals, Inc., based in Naples, Florida. The affected kit lots include WB00010 (Exp. Jan 2027), WB00017 and WB00019 (Exp. Feb 2027), WB00070 (Exp. Jun 2027), WB00077 and WB00078 (Exp. Jul 2027), and WB00130 (Exp. Nov 2027).

Why Was This Recall Issued?

The recall was initiated due to a CGMP (Current Good Manufacturing Practice) deviation. An out-of-specification, or OOS, result was observed for the Gliding Force functionality test during 12-month long term stability testing. This test measures how smoothly the syringe plunger moves during use, which is critical for the kit to properly reconstitute and deliver glucagon in an emergency situation.

Who Is Affected?

The recall affects patients and caregivers across the United States who rely on this kit to manage severe low blood sugar episodes, a condition most common among people with diabetes who use insulin. The product was distributed nationwide within the U.S. Firm notification to consignees and the public was made via e-mail. This is a voluntary, firm-initiated recall, and the FDA has listed the classification as not yet determined.

What Should You Do?

Patients, caregivers, pharmacies, and healthcare providers who have any of the affected lots should check their supply immediately against the lot numbers and expiration dates listed above. Because the Gliding Force issue could affect how reliably the syringe functions during an emergency, anyone with an affected kit should not assume it will work as intended. Consumers should contact their pharmacy or healthcare provider for guidance on replacing the product and should keep an alternative, unaffected glucagon emergency kit on hand if possible while resolving the issue. Any adverse events or quality problems experienced with this product should be reported to the FDA MedWatch program. Questions about the recall can be directed to Lupin Pharmaceuticals Inc. at its Naples, Florida offices.

Official Statement

According to the recall notice, this action was firm-initiated after the Gliding Force functionality test produced an out-of-specification result during stability testing. No press release has been issued for this recall, and the case remains listed as ongoing with no termination date recorded at this time.