Esomeprazole Magnesium is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Nexium 24HR
- Taken
- Oral
- Label
- Haleon US Holdings LLC, revised January 9, 2025 · full label on DailyMed
Purpose
Acid reducer
What it is used for
- treats frequent heartburn (occurs 2 or more days a week)
- not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Active ingredient
Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Do not use
if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
- had heartburn over 3 months. This may be a sign of a more serious condition.
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Ask a doctor or pharmacist before use if you are
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain
Warnings
Allergy alert
- Do not use if you are allergic to esomeprazole
- Esomeprazole may cause severe skin reactions. Symptoms include:
- skin reddening
- blisters
- rash If an allergic reaction occurs, stop use and seek medical attention right away. Do not use if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have
- had heartburn over 3 months. This may be a sign of a more serious condition.
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain Ask a doctor or pharmacist before use if you are
- taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Esomeprazole in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA)…
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
- Lots / codes
- Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
- Distribution
- Nationwide -in the USA
- Quantity
- 22,152 30 sachets/carton
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0443-2025
-
Class II Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA)…
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
- Lots / codes
- Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
- Distribution
- Nationwide -in the USA
- Quantity
- 30,674 30 sachets/carton
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0442-2025
-
Class III Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,…
Reason: Labeling: Not Elsewhere Classified – Wrong NDC number
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
- Lots / codes
- Lot#: M408002, Exp 05/31/2026
- Distribution
- USA Nationwide.
- Quantity
- 4404 packs
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0102-2025
-
Class III Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwa…
Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Lots, distribution and details
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
- Lots / codes
- Lot # 17220002, Exp Date 11/30/2023
- Distribution
- Nationwide in the USA
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Recall started
- October 23, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0112-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Esomeprazole Magnesium
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 61f67858-ba2f-449b-8b30-c15cdaf49222.