Why it was recalled
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0723-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 23, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 64,894 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0723-2026, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99296
- Address
- 5801 Pelican Bay Blvd Ste 500
- Code information
- 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.
- Postal code
- 34108-2734
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0723-2026
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 64,894 units
- Reason for recall
- CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the U.S.
- Recall initiation date
- Jun 23, 2026
- Initial firm notification
- Center classification date
- Jul 23, 2026