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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Esomeprazole Magnesium Oral Suspension Recalled for Wrong NDC Number

Agency Publication Date: December 4, 2024
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 4,404 packs of Esomeprazole Magnesium (esomeprazole magnesium) for Delayed-Release Oral Suspension (40 mg) because the packaging contains the wrong National Drug Code (NDC) number. This prescription medication is sold in cartons containing 30 single-dose packets. The recall specifically affects lot M408002 with an expiration date of May 31, 2026.

Risk

The presence of an incorrect NDC number on the product label can lead to dispensing errors at pharmacies or billing inaccuracies. If a patient receives the wrong medication or dosage due to labeling confusion, it could lead to ineffective treatment or adverse health effects.

What You Should Do

  1. This recall affects Esomeprazole Magnesium for Delayed-Release Oral Suspension (40 mg) sold under the Zydus brand in cartons of 30 single-dose packets with NDC 68382-849-94.
  2. Identify if your product is affected by checking the carton for lot number M408002 and an expiration date of 05/31/2026.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Zydus Pharmaceuticals (USA) Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Esomeprazole Magnesium for Delayed-Release Oral Suspension (40 mg)
Variants: 30 Single-Dose Packets, 40 mg
Lot Numbers:
M408002 (Exp 05/31/2026)
NDC:
68382-849-94

Distributed by Zydus Pharmaceuticals (USA) Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95767
Status: Active
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Pharmacies; Wholesalers
Manufactured In: India, United States
Units Affected: 4404 packs
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.