CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
GlucaGen HypoKit (glucagon [rDNA origin] for injection) recalled
Novo Nordisk is recalling GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, distributed nationwide in the US. The recall was initiated on 8 Sep 2016 and the FDA has classified it as Class I.
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-0217-2017
- FDA event ID
- 75123
- Recalling firm
- Novo Nordisk, Plainsboro, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Sep 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Sep 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +105 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective delivery system: detached needles on the syringe in the kit.
Product as listed by the FDA
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
Where it was distributed
Nationwide and Worldwide
Questions about this recall
Why was it recalled?
Defective delivery system: detached needles on the syringe in the kit.
Which lots are affected?
Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017
Where was it sold?
Nationwide and Worldwide
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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