D-0723-2026 Class II Ongoing
FDA drug recall D-0723-2026 was initiated by Lupin Pharmaceuticals Inc. on June 23, 2026 and is designated Class II. Reason for recall: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. The recall status is ongoing. Affected quantity: 64,894 units.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- June 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,894 units
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
Reason for Recall
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Distribution Pattern
Nationwide within the U.S.
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.