CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report
Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalled
Lupin Pharmaceuticals is recalling Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, distributed nationwide in the US. The recall was initiated on 23 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0723-2026
- FDA event ID
- 99296
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Brand
- Glucagon
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2026
- FDA classified
- 23 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Jun 2026 | Recall initiated by company | |
| 8 Jul 2026 | Published in enforcement report | +15 days |
| 23 Jul 2026 | Classified by FDA | +15 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the U.S.
Questions about this recall
Why was it recalled?
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Which lots are affected?
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 was it sold?
Nationwide within the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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