Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Adrenalin (epinephrine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDCs
0404-9810-01
42023-0159-25
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Adrenalin epineprine NDC 00404-9810 |
EPINEPHRINE 1 mg/mL | Injection Intramuscular|intravenous|subcutaneous |
Henry Schein, Inc. | Rx |
| Adrenalin epinephrine NDC 42023-0159 |
1 mg/mL | Injection Intramuscular|intravenous|subcutaneous |
Par Health USA, LLC | Rx |
- Recalling firm
- Henry Schein Inc. and Glove Club HSI Gloves Inc.
- NDC code
- 42023-159-25
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0342-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Epinephrine recalls
See all
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other labeling / mix-up recalls from 2024
All labeling / mix-up recalls
Class I · High risk
Adrenalin Chloride Solution
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class III · Low risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
LABELING: LABEL MIX-UP
Class III · Low risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops
LABELING: LABEL MIX-UP
Class III · Low risk
Diphenhydramine HCl 50 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
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