CLASS II ONGOING Drug recall · Reported 28 May 2025 · FDA Enforcement Report
Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg single dose packets per, distributed nationwide in the US. The recall was initiated on 13 May 2025 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-0443-2025
- FDA event ID
- 96860
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2025
- FDA classified
- 20 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 13 May 2025 | Recall initiated by company | |
| 20 May 2025 | Classified by FDA | +7 days |
| 28 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide -in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Which lots are affected?
Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
Where was it sold?
Nationwide -in the USA
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 products in this recall event
1 other product · FDA event 96860| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Esomeprazole recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalledEsomeprazole Magnesium | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg recalledEsomeprazole Magnesium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalledEsomeprazole Magnesium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |