CLASS II Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalled
Henry Schein Inc. and Glove Club HSI Gloves is recalling Adrenalin (epinephrine) Injection 1mg/mL single dose vial, distributed nationwide in the US. The recall was initiated on 17 Jan 2024 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-0342-2024
- FDA event ID
- 93839
- Recalling firm
- Henry Schein Inc. and Glove Club HSI Gloves, Melville, NY
- Brand
- Adrenalin
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 17 Jan 2024
- FDA classified
- 21 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Allergy Medication
Timeline
| 17 Jan 2024 | Recall initiated by company | |
| 21 Feb 2024 | Classified by FDA | +35 days |
| 28 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Which lots are affected?
Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26
Where was it sold?
USA nationwide.
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.
Other Epinephrine recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine | International Medication Systems | Sterility | Nationwide |
| Drug | CLASS II | EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | EPINEPHrine 8mg/ added to dextrose 5%, 32 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |