FDAFDA recall D-0723-2026 · Jul 8, 2026
Lupin Pharmaceuticals Inc.: Glucagon Emergency Kit for Low Blood Sugar recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- 64,894 units
- Distribution
- Nationwide within the U.S.
- Recalling firm
- Lupin Pharmaceuticals Inc., Naples, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-23
Source: openFDA enforcement record D-0723-2026 · search recall number D-0723-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.