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 Chloride Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
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 Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Affected NDC
42023-0103-01
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
- Recalling firm
- ENDO USA, Inc.
- NDC code
- 42023-103-01
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Dec 20, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0223-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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 recalls by ENDO USA, Inc.
All 2024 recalls
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class III · Low risk
Everolimus tablets 2.5 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 10 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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