June 2026 FDA Recall Glucagon by Lupin Pharmaceuticals Inc.
D-0723-2026 - CGMP deviation
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on June 23, 2026 for the product Glucagon. The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0723-2026
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
06-23-2026
07-08-2026
64,894 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the U.S.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 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.
