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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Pharmaceuticals (USA) Inc: Lansoprazole Delayed-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: November 3, 2020
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 14,748 units of Lansoprazole Delayed-Release Orally Disintegrating Tablets, a medication used to treat stomach acid-related conditions. The recall was initiated because the tablets failed dissolution specifications, meaning the medication may not dissolve at the correct rate in the body. This defect could potentially reduce the effectiveness of the drug or cause it to be released into the system improperly.

Risk

The failure to meet dissolution specifications means the tablets may not release the active ingredient properly, which can prevent the patient from receiving the intended therapeutic dose and potentially lead to inadequate treatment of their condition.

What You Should Do

  1. Check your medication packaging for Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg (NDC 68382-771-77) in 100-count cartons with Lot # M005681 and an expiration date of 3/2022.
  2. Check your medication packaging for Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg (NDC 68382-772-77) in 100-count cartons with Lot # M005682 and an expiration date of 3/2022.
  3. If you have an affected product, contact your healthcare provider or pharmacist for guidance before you stop taking the medication.
  4. Return any unused product to the pharmacy or place of purchase for a refund.
  5. Contact Zydus Pharmaceuticals (USA) Inc. at their Pennington, New Jersey office for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton
Model:
NDC 68382-771-77
Recall #: D-0074-2021
Lot Numbers:
M005681 (EXP 3/2022)
Date Ranges: EXP 3/2022
Product: Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton
Model:
NDC 68382-772-77
Recall #: D-0075-2021
Lot Numbers:
M005682 (EXP 3/2022)
Date Ranges: EXP 3/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86663
Status: Resolved
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: pharmacies nationwide
Manufactured In: India, United States
Units Affected: 2 products (6,840 units; 7,908 units)
Distributed To: Nationwide
Agency Last Updated: November 10, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.