Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydu
Summary
The FDA issued a Class III for Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose by Zydus Pharmaceuticals (USA) Inc. Reason: Labeling: Not Elsewhere Classified - Wrong NDC number.
Details
Source
Drug Recall
External ID
D-0102-2025
Action Date
2024-12-11
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot#: M408002, Exp 05/31/2026
Quantity Affected: 4404 packs
Reason for Recall
Labeling: Not Elsewhere Classified - Wrong NDC number
Distribution
USA Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-14
Company
Pennington, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 64 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0102-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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