CLASS III ONGOING Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report
Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg-Dose Packets, distributed nationwide in the US. The recall was initiated on 14 Nov 2024 and the FDA has classified it as Class III.
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-0102-2025
- FDA event ID
- 95767
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 14 Nov 2024
- FDA classified
- 4 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 14 Nov 2024 | Recall initiated by company | |
| 4 Dec 2024 | Classified by FDA | +20 days |
| 11 Dec 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: Not Elsewhere Classified - Wrong NDC number
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
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
Where it was distributed
USA Nationwide.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified - Wrong NDC number
Which lots are affected?
Lot#: M408002, Exp 05/31/2026
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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|---|---|---|---|---|---|
| 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 |
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| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
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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 II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | 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 |